Reinforced therapeutic wrap and method

ABSTRACT

A therapy wrap for treatment of at least a portion of an animate body having improved kink resistance. The therapy wrap may be selectively reinforced for improved kink resistance in only a portion of the wrap. The reinforcement may decrease the kink radius. The wrap may include a kink reducer in all or only a selected kink-prone region. The kink reducer may be selectively configured attachment points or spot welds. The therapy wrap may include a reinforcement layer of one or more discrete reinforcement members. The wrap may be formed by pre-tensioning the material layers while forming the fluid bladder and/or gas pressure bladder. The therapy wrap may be adapted to compensate for conditions that normally cause kinking of the wrap or buckling of the fluidic channels. Also disclosed are methods of manufacturing the wrap and methods of administering a temperature-controlled treatment to an anatomical body part.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/982,266, filed on Dec. 30, 2010, titled “REINFORCEDTHERAPEUTIC WRAP AND METHOD,” now U.S. Pat. No. 8,597,217, which isherein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates generally to therapy of an animate body,and more particularly a therapeutic wrap of the type having circulatingfluid to provide cooling, heating, and/or compression to a human oranimal body part.

BACKGROUND

It is now common to apply cold and compression to a traumatized area ofa human body to facilitate healing and prevent unwanted consequences ofthe trauma. In fact, the acronym RICE (Rest, Ice, Compression andElevation) is now used by many.

Typically thermally-controlled therapy involves cold packing with icebags or the like to provide deep core cooling of a body part. Therapyoften involves conventional therapy wraps with a fluid bladder forcirculating a cooled heat exchange medium. Elastic wraps are oftenapplied over the therapy wrap to provide compression.

More recently therapy wraps including a pair of compliant bladders tocontain fluids have been disclosed. The therapy wrap typically has acompliant bladder for containing a circulating heat exchange liquidalone or in combination with a compressive bladder which overlays thecompliant bladder for pressing the bladder against the body part to besubjected to heat exchange. In general, the body heat exchangingcomponent(s) of such an apparatus include a pair of layers defining aflexible fluid bladder through which a liquid is circulated. Thestructure embodying both the liquid bladder and compressive bladdercomponent is often referred to as a “wrap.” The liquid fed to the wrapis maintained at a desired temperature by passing the liquid through aheat exchanging medium such as an ice bath or a refrigeration unit. Onesuch system is disclosed, for example, in U.S. Pat. No. 6,178,562 toElkins, the disclosure of which is herein incorporated for all purposesby reference.

Therapy wraps can be used to provide therapy in a variety of contextswhether for humans, equine animals, dogs, or any other mammal. Therapywraps can be shaped and designed for application to a variety ofanatomical body parts such as a hoof, a shoulder, a knee, a leg, a head,and more.

A problem occurs when applying the wrap to such complex shapes. Bendingof the wrap in one or more directions can cause localized kinking orbuckling in the bladder. In some cases, one or more fluid pathwaysbecomes crimped or completely occluded, thereby inhibiting fluid flowand operation. This type of kinking generally occurs because of theinability of the material to conform to the complex shape of theanatomical part to which it is applied. It is believed that, in part,the material collapses and/or bunches when wrapped around tightradiuses.

Kinking may also occur with therapeutic wraps having two bladders fixedtogether. As the wrap is bent or folded, the bladders cannot shear ormove past one another. This type of kinking is sometimes referred to asbuckling.

It is believed that the above and other types of kinking conditions arefurther exacerbated by the compressive force on the compliant fluidbladder. The compressive force promotes further kinking after the wallsof the bladder begin to kink.

Kinking leads to several performance problems. Kinking of the fluidicchannels can lead to cool spots that are uncomfortable for the user andrender heat transfer inconsistent. Kinking can also undesirably increasebackpressure in local regions of the fluid bladder. In the case ofsevere kinking, fluid flow is completely stopped through a fluidflowpath and heat exchange cannot occur.

To date, the effects of kinking in the context of therapy wraps have notbeen adequately explored. One existing wrap design provides a fluidbladder with a plurality of spot welds (also referred to as “dots”) toreduce “ballooning.” An example of such a fluid bladder is disclosed inU.S. Pat. No. 6,695,872 to Elkins. The dots also effectively split thefluid pathway into a plurality of fluidic channels. The conventional useof dots is limited in that such fluid bladders experience an undesirablylarge number of kink failures and other failure modes during use,especially when applied to complex body parts and/or in compression froma pressure bladder.

The risk of kinking may be reduced by increasing the rigidity of thematerials forming the bladder. Among the many limitations of thisapproach, increasing the rigidity of the materials detrimentallyrequires a trade-off between conformability of the wrap and kinkresistance.

There remains the need for providing improved wraps with good heatexchange performance and increased resistance to kinking, in particularwhen conformed and compressed to complex shapes or bent around a tightradius curve. Even if a complete blockage of the fluidic channel doesnot occur, an undesirable reduction of fluid flow generally decreaseswrap performance.

There is the need for a wrap that is conformable to a complex anatomicalshape and provides efficient heat transfer over the treatment surfaceunder compressive force. There is a need for a wrap that reduces therisk of kinking or buckling. There is the need to provide a wrap thatimproves patient comfort.

There is the need for a therapeutic wrap that overcomes the above andother problems. There remains a need to provide improvedtemperature-controlled therapy apparatus and methods for their use.

SUMMARY OF THE DISCLOSURE

The present invention involves improvements in heat transfer therapyapparatus and avoids disadvantages in the prior art.

Various aspects of the invention are directed to a therapy wrap withimproved kink resistance. In various embodiments, the therapy wrap isselectively reinforced for improved kink resistance in only a portion ofthe wrap. In various embodiments, the wrap has a decreased kink radius.In various embodiments, one or more selected regions are modified tohave an increased kink resistance. Various aspects of the invention aredirected to a therapy wrap for providing heating or cooling to ananatomical body part requiring treatment.

Various aspects of the invention are directed to a therapy wrapincluding a flexible fluid bladder for containing a heat exchangemedium, the fluid bladder including an inlet, an outlet, a fluidflowpath connecting the inlet and the outlet, and a plurality ofattachment points connecting walls of the bladder and defining aplurality of fluidic channels in the flowpath; and a gas pressurebladder for applying a compressive force to a portion of the fluidbladder in contact with the body part. The attachment points arepositioned and dimensioned to increase resistance to kinking of thefluid bladder.

Various aspects of the invention are directed to a therapy wrap forproviding heating or cooling to an anatomical body part, the wrapincluding a flexible fluid bladder for containing a heat exchangemedium, the fluid bladder including an inlet, an outlet, a fluidflowpath connecting the inlet and the outlet, and a plurality ofattachment points connecting walls of the bladder and defining aplurality of fluidic channels in the flowpath; and a gas pressurebladder overlaying the fluid bladder for applying a compressive force toa portion of the fluid bladder in contact with the body part. A portionof the plurality of attachment points may be positioned and dimensionedto increase resistance to kinking of the fluid bladder in a region ofthe fluid bladder prone to kinking during use.

In various embodiments, the attachment points are dots formed by spotwelding. In various embodiments, the attachment points arecircular-shaped and have an essentially equal diameter. In variousembodiments, the attachment points have a diameter between about 0.15inch and about 0.2 inch. The attachment points may a diameter beingbetween about 0.15 inch and about 0.35 inch. The attachment points mayhave an average center-to-center spacing between adjacent attachmentpoints between about 0.35 inch and about 0.75 inch. The attachmentpoints may have an average center-to-center spacing between adjacentattachment points between about 0.35 inch and about 0.5 inch. Theattachment points may have an average edge-to-edge spacing betweenadjacent attachment points between about 0.2 inch and about 0.5 inch.The attachment points may have an average edge-to-edge spacing betweenadjacent attachment points between about 0.2 inch and about 0.25 inch.

In various embodiments, a ratio of the fluid volume of the fluid bladderto a treatment area of the fluid bladder is between about 1 L/m² andabout 3.5 L/m² at 10 psi. The ratio of the fluid volume of the fluidbladder to a treatment area of the fluid bladder may be between about 1L/m² and about 1.5 L/m² at 10 psi. The ratio of the fluid volume of thefluid bladder to a treatment area of the fluid bladder may be betweenabout 1.2 L/m² and about 3 L/m² at 20 psi.

The ratio of the fluid volume of the fluid bladder to a treatment areaof the fluid bladder may be at least about 1 L/m² at 5 psi.

In various embodiments, the fluidic channels are dimensioned to increasekink resistance. In various embodiments, the average fluidic channelcross-sectional area in a kink-resistant region is about 0.02 inch², andmore preferably 0.0254 inch². In various embodiments, the averagefluidic channel cross-sectional area in a kink-resistant region isbetween about 10 mm² and about 40 mm², more preferably between about 15mm² and about 25 mm².

In various embodiments, the compressive force is in a range from about0.25 psi to about 3 psi. In various embodiments, the compressive forceis in a range from 0 psi to about 5 psi.

Various aspects of the invention are directed to a therapy wrap forproviding treatment to an anatomical body part, the wrap including aflexible fluid bladder for containing a heat exchange medium andincluding an inlet, an outlet, and a fluid flowpath connecting the inletand the outlet; a gas pressure bladder overlaying the fluid bladder forapplying a compressive force to a portion of the heat exchanger incontact with the body part; and a kink reducer for selectivelyincreasing kink resistance of the fluid bladder in a kink-resistant zonesubject to the compressive force, the kink-resistant zone beingpositioned only along a portion of the at least one fluidic channelspaced from the inlet and outlet. Various aspects of the invention aredirected to a therapy wrap conformable to an anatomical body partincluding a flexible heat exchanger for containing a heat exchangemedium and including an inlet, an outlet, and a fluid flowpathconnecting the inlet and the outlet; a gas pressure bladder for applyinga compressive force to a portion of the heat exchanger in contact withthe body part; and a kink reducer for selectively increasing kinkresistance of the heat exchanger in a kink-resistant zone subject to thecompressive force. In various embodiments, the kink reducer is a memberselected from the group consisting of a plurality of dot connections, adiscrete reinforcement member, and a combination of the same. In variousembodiments, the kink-resistant zone being positioned only along aportion of the at least one fluidic channel distally from the inlet andoutlet. In various embodiments, the kink-resistant zone being positionedonly along a portion of the at least one fluidic channel spaced from theinlet and outlet.

In various embodiments, the wrap further includes a plurality ofcircular-shaped attachment points connecting opposite walls of the heatexchanger interiorly of a periphery of the heat exchanger and defining aplurality of fluidic channels in the flowpath. The kink reducer mayinclude attachment points having a variable spacing between adjacentpoints positioned and dimensioned to increase resistance to localkinking of the heat exchanger. In various embodiments, the fluid bladderis formed of one of polyurethane, nylon, and a combination of the same.

In various embodiments, an average spacing between adjacent attachmentpoints in the kink-resistant zone may be greater than an average spacingbetween adjacent attachment points in the remainder of the heatexchanger. The average spacing in the kink-resistant zone may be atleast 20% greater than the average spacing in the remainder of the heatexchanger. The average spacing in the kink-resistant zone may be atleast 25%, at least about 30%, at least about 40%, at least about 50%,or at least about 75% greater than the average spacing in the remainderof the heat exchanger.

In various embodiments, an average edge-to-edge spacing between adjacentattachment points in the kink-resistant zone is between about 0.2 inchand about 0.5 inch.

In various embodiments, the attachment points are spot welds. In variousembodiments, the attachment points are dots.

In various embodiments, the plurality of attachment points in thekink-resistant zone are positioned in a non-linear pattern.

In various embodiments, the plurality of fluidic channels in thekink-resistant zone have a cross-sectional area greater than across-sectional area of the fluidic channels in the remainder of thefluid bladder.

In various embodiments, the kink-resistant zone has a tensile bendingstrength increased by at least 20%, at least 30%, at least 40%, at least50%, at least 75%, or at least 100%. In various embodiments, thekink-resistant zone has a tensile bending strength at least 75% greaterthan the remainder of the heat exchanger.

In various embodiments, the wrap includes a selectively reinforced dotpattern to increase the local tensile strength by at least about 10%,and more preferably at least about 20%, at least about 50%, at leastabout 75%, at least about 100%, or at least about 150%. In variousembodiments, the selectively reinforced dot pattern is configured toreduce the occurrence of kinking during use by at least about 10%, andmore preferably at least about 20%, at least about 50%, or at leastabout 75%.

In various embodiments, the heat exchanger is a fluid bladder forcontaining cooled water and the gas pressure bladder is for containingpressurized air. In various embodiments, when the fluid bladder isfilled with water at 19 psi, the fluidic channels in the kink-resistantzone provide at least about 10 pounds of resistive force when displacedby about 0.1 inches over about a 2-inch diameter area. In variousembodiments, the fluidic channels provide at least about 5 pounds whendisplaced by about 0.13 inch, at least about 11 pounds when displaced byabout 0.11 inch, at least about 17 pounds when displaced by about 0.1inch, at least about 22 pounds when displaced by about 0.09 inch, and/orat least about 27 pounds when displaced by about 0.08 inch.

In various embodiments, a ratio of the fluid volume of the heatexchanger to a treatment area of the heat exchanger is between isbetween about 1 L/m2 and about 3.5 L/m2 when the fluid in the heatexchanger is at 10 psi.

In various embodiments, the wrap includes a check valve or flowrestrictor to maintain backpressure in the fluid bladder.

In various embodiments, the kink reducer comprises a discretereinforcement member to impart significantly increased resistance tokinking in the kink-resistant zone relative to the remainder of the heatexchanger. In various embodiments, the kink reducer comprises a discretereinforcement member coupled to the fluid bladder in the kink-resistantzone. In various embodiments, the reinforcement member increases thetensile bending strength of the kink-resistant zone by at least 75%relative to the remainder of the heat exchanger. In various embodiments,the reinforcement member increases the tensile bending strength of thekink-resistant zone by at least 25%, by at least 50%, or by at least 75%relative to the remainder of the heat exchanger. The reinforcementmember may be a rigid body having a shape selected from a wire, anexoskeleton, a ribbon, and a sheet.

In various embodiments, the reinforcement member is a rigid memberselected from the group consisting of a wire, an exoskeleton, a ribbon,a sheet, and a combination of the same.

In various embodiments, the wrap includes a plurality of dot connectionsand a discrete reinforcement member. The dot connections may be formedin a region overlapping the reinforcement member. The reinforcementmember may overlap the dot connections. The reinforcement member and dotconnections may be positioned in the same region.

In various embodiments, the reinforcement member is positioned withinthe gas pressure bladder. In various embodiments, a position of thekink-resistant zone corresponds to an anatomical joint of a patient tobe treated. The body part may be a back of a joint. The kink-resistantzone may correspond to one of a back of a knee or a back of an elbow. Aposition of the kink zone may correspond to a narrowed region of thecommon border. In various embodiments, the heat exchanger and gaspressure bladder are integrally connected and fluidly separated by acommon wall.

In various embodiments, the kink reducer is a member selected fromattachment points, a discrete reinforcement member, and a combination ofthe same as described in any of paragraphs [0020] to [0040] above. Invarious embodiments, the kink-reducer is a pre-tensioned regionmanufactured as described in any of paragraphs [0058] to [0073] below.The kink reducer may be modified to achieve a desired variation in kinkresistance.

Various aspects of the invention are directed to a therapy wrap forproviding treatment to an anatomical body part, the wrap including afirst outer layer of flexible material;

a second outer layer of flexible material; a middle layer between thefirst and second layers of flexible material; a plurality of connectionsjoining the first and middle layers to form a fluid bladder, theplurality of connections comprising dots and fences defining a pluralityof fluidic channels in the fluid bladder; the fluid bladder comprising afirst zone and a second zone of dots; and a border joining the secondouter layer and middle layer to form a gas pressure bladder. The dots inthe second zone may be positioned and configured to increase a bendingstrength of the second zone relative to the first zone when the wrap isin use. A portion of the dots in the fluid bladder may be positioned andconfigured to increase a bending strength of a local region relative tothe remainder of the wrap when it is in use. Various aspects of theinvention are directed to a therapy wrap conformable to an anatomicalbody part including a first outer layer of flexible material; a secondouter layer of flexible material; a middle layer between the first andsecond layers of flexible material; and a border joining the secondouter layer and middle layer to form a gas pressure bladder.

In various embodiments, a plurality of connections join the first andmiddle layers to form a fluid bladder. The plurality of connections mayinclude dots and fences defining a plurality of fluidic channels in thefluid bladder. In various embodiments, the fluid bladder includes afirst zone and a second zone of dots; the dots in the second zoneincrease a bending strength of the second zone relative to the firstzone when the wrap is in use.

In various embodiments, the plurality of connections are welds betweenthe first outer layer and middle layer.

In various embodiments, the dots in the second zone have an averageedge-to-edge spacing between about 0.2 inch and about 0.5 inch. The dotsin the second zone may have an essentially equal diameter, the diameterof the dots being between about 0.15 inch and about 0.35 inch.

In various embodiments, the plurality of connections joining the firstand middle layer include a common border along a periphery of the firstand middle layer and a plurality of fences interiorly of the commonborder defining a fluid flowpath, the plurality of dots dividing thefluid flowpath into the plurality of fluidic channels.

In various embodiments, in the second zone, the dots inward of theborder are larger than those adjacent the border. In variousembodiments, in the second zone, the dots have a variable diameter.

In various embodiments, the dots are attachment points configured anddimensioned as described in any of paragraphs [0020] to [0035].

Various aspects of the invention are directed to a therapy wrap asdescribed in any of paragraphs [0018] to [0049].

Various aspects of the invention are directed to a method of forming atherapy wrap as described in any of paragraphs [0018] to [0050].

Various aspects of the invention are directed to a method of forming aflexible wrap for thermal therapy, the method including joining a firstlayer of flexible material to a second layer of flexible material toform at least one interior fence, the at least one fence defining atleast one fluid pathway between the first layer and second layer; andjoining the first layer to the second layer to form a plurality of dotsdefining a plurality of fluidic channels in the at least one fluidpathway, a portion of the plurality of dots corresponding to akink-prone region of the wrap and the dots in the portion sized andshaped to increase resistance to kinking in the kink-prone region. Invarious embodiments, the joining to form the multi-chamber wrap isperformed simultaneously with the forming of the at least one interiorfence and the forming of the dots. In various embodiments, the formingof the at least one fence comprises forming the at least one fence toextend through the second layer and third layer.

Various aspects of the invention are directed to a method of forming aflexible wrap for thermal therapy and conformable to an anatomical bodypart, the method including forming a plurality of connections joining afirst layer of flexible material and a second layer of flexiblematerial; joining a third layer of flexible material, the second layerof flexible material, and the first layer of flexible material along aperipheral border; and forming at least one fence and a plurality ofdots between the first layer and the second layer and interiorly of theperipheral border. The at least one fence defines at least one fluidpathway between the first layer and second layer. The plurality of dotsdefine a plurality of fluidic channels in the at least one fluidpathway. In various embodiments, the forming of the dots includesforming a dot matrix in a first zone and a dot matrix in a second zonealong the at least one fluid pathway, the second zone corresponding to akink-prone region of the wrap, the dot matrix in the second zone toincrease resistance to kinking within a localized area of the dots. Invarious embodiments, the dot matrix in the second zone is formed withoutany linear arrangement. In various embodiments, the dot matrix in thesecond zone is formed in a non-linear arrangement.

In various embodiments, the forming of the plurality of dots comprisesforming a repeating pattern of essentially aligned dots in the firstzone. The forming of the at least one fence may include forming the atleast one fence to extend between the second layer and third layer.

In various embodiments, the forming of the plurality of dots isaccomplished by increasing a spacing between adjacent dots in the secondzone relative to a spacing between adjacent dots in the first zone.

In various embodiments, the plurality of dots in the second zone have anessentially equal diameter, the diameter of the dots being between about0.15 inch and about 0.35 inch.

In various embodiments, the kink-prone region corresponds to ananatomical joint. The kink-prone region may correspond to a narrowedregion of the first and second layers.

Various aspects of the invention are directed to a method of forming aheat exchanger, the method including sealing a first layer of flexiblematerial to a second layer of flexible material to form a peripheralborder and a fluid pathway; and attaching a selective reinforcementlayer to the second layer along a portion of the fluid pathwaycorresponding to a kink-prone region.

In various embodiments, the method includes attaching the selectivereinforcement layer along another portion of the fluid pathway. Thereinforcement layer may include a substrate carrying a rigid structuralmember. The structural member may be a substantially flat batten formedof stiffened urethane. The structural member may be attached only alongthe portion of the fluid pathway corresponding to the kink-prone region.The reinforcement layer may be positioned on an opposite side of thesecond layer from the first layer.

In various embodiments, the method further includes attaching anotherreinforcement layer to the second layer along a different portion of thefluid pathway than the reinforcement layer. In various embodiments, theanother reinforcement layer and reinforcement layer are integrallyformed. The another reinforcement layer and reinforcement layer may bespaced from an inlet and an outlet of the fluid pathway.

Various aspects of the invention are directed to a method of making aheat exchanger conformable to a complex shape, the method includingforming a first layer of a flexible material; forming a second layer ofa flexible material; sealing the first layer to the second layer along acommon border; securing the first layer to the second layer interiorlyof said border to define at least one fluidic channel in a first region;securing the first layer to the second layer interiorly of said borderto define another fluidic channel in a second region; and attaching aselective reinforcement layer only along the another fluidic channel inthe second region.

In various embodiments, the reinforcement layer comprises a substratecarrying a rigid structural member. The structural member may be asubstantially flat batten. The structural member may be formed ofstiffened urethane.

In various embodiments, the reinforcement layer is positioned on anopposite side of the second layer from the first layer.

Various aspects of the invention are directed to a method of forming atherapy wrap, the method including tensioning a member selected from thegroup consisting of a first layer of flexible material, a second layerof flexible material, and a combination of the same; during thetensioning, sealing the second layer over the first layer along a commonborder to form a bladder.

In various embodiments, the method further includes, after the sealing,releasing the formed bladder. The tensioning may be performed in only akink-prone region of the selected member.

In various embodiments, the method includes sealing a third layer offlexible material over the second layer along the common border to formanother bladder, the another bladder attached to and overlaying thebladder. The sealing to form the first bladder or sealing to form thesecond bladder may include forming a plurality of interior controlfences extending through the second layer and defining at least onefluid flowpath in the bladder and the another bladder. The sealing ofthe first layer to the second layer and the sealing of the second layerto the third layer may be performed substantially simultaneously.

In various embodiments, the tensioning includes heating the selectedmember. In various embodiments, the tensioning includes stretching theselected member.

Various aspects of the invention are directed to a method of making atherapy wrap which is conformable to an anatomical joint, the methodincluding forming a first outer layer of a flexible material; forming amiddle layer of flexible material overlaying the first outer layer;pre-tensioning at least one of the first outer layer and middle layer;and while the kink-resistant zone remains pre-tensioned, sealing thefirst outer layer to the middle layer along a common peripheral borderto form a fluid bladder.

In various embodiments, the pre-tensioning of at least one of the firstouter layer and the middle layer is performed in only a selectedkink-resistant zone of the layers. In various embodiments, thepre-tensioning is performed to a selected region positioned remotelyfrom the inlet and the outlet.

In various embodiments, the method includes forming a second outer layerof a flexible material overlaying the middle layer; and sealing thesecond outer layer to the middle layer to form a gas pressure bladder.

The kink-resistant zone may correspond to a location of an apex of theanatomical joint requiring treatment.

In various embodiments, the sealing to form a fluid bladder includesforming a plurality of control fences extending through the first outerlayer, the middle layer, and the second outer layer, interiorly of saidborder, to foam at least one fluid flowpath in the fluid bladder and thegas pressure bladder. The sealing of the first outer layer to the middlelayer and the sealing of the second outer layer to the middle layer maybe performed essentially simultaneously.

In various embodiments, the pre-tensioning comprises heating the atleast one of the first outer layer and the middle layer prior to thesealing.

In various embodiments, a therapy wrap for providing heating or coolingto an anatomical body part is provided. The wrap may include a flexiblefluid bladder for containing a heat exchange medium, the fluid bladderincluding an inlet, an outlet, and a fluid flowpath connecting the inletand the outlet; a gas pressure bladder overlaying the fluid bladder forapplying a compressive force to a portion of the fluid bladder incontact with the body part; and a reinforcement member disposed withinthe gas pressure bladder at one or more kink prone regions of the gaspressure bladder, wherein the reinforcement member reduces kinking atthe one or more kink prone regions of the gas pressure bladder.

In some embodiments, the reinforcement member is a made from a porousmaterial. In some embodiments, the porous material has an open cell foamstructure that is gas permeable.

In some embodiments, the reinforcement member has a hole and a weld thatpasses through the hole that secures the reinforcement member within thegas pressure bladder. In some embodiments, the reinforcement member isdonut shaped.

In some embodiments, the reinforcement member is secured to the gaspressure bladder with an adhesive.

In some embodiments, the therapy wrap further includes a plurality ofattachment points connecting walls of the bladder and defining aplurality of fluidic channels in the flow path. In some embodiments, thereinforcement member is secured within the gas pressure bladder with aweld that is aligned with one of the attachment points.

In some embodiments, the size and shape of the reinforcement member isdefined at least in part by one or more of the plurality of attachmentpoints within the bladder.

In some embodiments, the reinforcement member is curvilinear. In someembodiments, the reinforcement member is circular or oval.

In some embodiments, the reinforcement member is rectilinear. In someembodiments, the reinforcement member is square or rectangular.

In some embodiments, the size and shape of the reinforcement member isdefined at least in part by a perimeter of the gas pressure bladder. Insome embodiments, the size and shape of the reinforcement member isdefined at least in part by one or more interior fences disposed withinthe fluid bladder or gas pressure bladder.

In some embodiments, the reinforcement member is made from an insulatingmaterial. In some embodiments, reinforcement member is adhered to a wallof the gas pressure bladder that is adjacent or shared with the fluidbladder.

In some embodiments, a therapy wrap for providing treatment to ananatomical body part is provided. The wrap may include a gas pressurebladder for applying a compressive force to the body part; and areinforcement member disposed within the gas pressure bladder at one ormore kink prone regions of the gas pressure bladder, wherein thereinforcement member reduces kinking at the one or more kink proneregions of the gas pressure bladder.

In some embodiments, the reinforcement member is a made from a porousmaterial. In some embodiments, the porous material has an open cell foamstructure that is gas permeable.

In some embodiments, the reinforcement member has a hole and a weld thatpasses through the hole that secures the reinforcement member within thegas pressure bladder. In some embodiments, the reinforcement member isdonut shaped.

In some embodiments, the reinforcement member is secured to the gaspressure bladder with an adhesive. In some embodiments, thereinforcement member is secured within the gas pressure bladder with oneor more welds.

In some embodiments, the reinforcement member is curvilinear. In someembodiments, the reinforcement member is circular or oval.

In some embodiments, the reinforcement member is rectilinear. In someembodiments, the reinforcement member is square or rectangular.

In some embodiments, the size and shape of the reinforcement member isdefined at least in part by a perimeter of the gas pressure bladder. Insome embodiments, the size and shape of the reinforcement member isdefined at least in part by one or more interior attachment featuresdisposed within the gas pressure bladder.

The therapeutic wrap and method of the present invention have otherfeatures and advantages which will be apparent from or are set forth inmore detail in the accompanying drawings, which are incorporated in andform a part of this specification, and the following DetailedDescription of the Invention, which together serve to explain theprinciples of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a reinforced therapeutic wrap for astraight knee in accordance with the invention, the wrap configured toreduce kinking during operation.

FIG. 2 is an enlarged detail view of the wrap of FIG. 1, illustrating avariable dot pattern in a kink-resistant zone of the fluid bladder.

FIG. 3 illustrates a sectional view of the wrap of FIG. 2 through theline 3-3, illustrating the expandable compression bladder and fluidbladder within a sleeve along with an optional reinforcement member.

FIG. 4 is an schematic drawing representative of an enlarged portion ofthe wrap of FIG. 3, illustrating a plurality of fluidic channelsexpanded with fluid.

FIG. 5 is a top plan view of another selectively reinforced therapeuticwrap similar to the wrap of FIG. 1, the wrap configured for a canine.

FIG. 6 is a top plan view of another selectively reinforced therapeuticwrap similar to the wrap of FIGS. 1 and 5, the wrap configured for ahuman shoulder.

FIG. 7 is an enlarged detail view of the wrap of FIG. 6, illustratingvariable dot patterns in a narrow connecting region between flaps.

FIG. 8 is a top plan view of a therapeutic wrap for a horse hoof inaccordance with the invention, illustrating various kink-resistant zoneswith different reinforcement member positions and configurations.

FIG. 9 is a top plan view of another selectively reinforced therapeuticwrap similar to the wrap of FIG. 8, illustrating use of fourreinforcement members configured to provide kink resistance duringoperation.

FIGS. 10A, 10B, and 10C illustrate a method of assembling a therapeuticwrap similar to that of FIG. 9 in accordance with the invention.

FIGS. 10D-10G illustrate an embodiment of a therapeutic wrap with areinforcement member disposed in a gas bladder.

FIGS. 10H and 10I illustrate additional embodiments of a reinforcementmember disposed in a gas bladder.

FIG. 11 is a top plan view of a selectively reinforced heat exchangedevice similar to the wrap of FIG. 1 for use with an elastic wrapinstead of a gas pressure bladder, illustrating dot connectionsconfigured to provide kink resistance during operation.

FIG. 12 is a graph illustrating force versus fluidic channeldisplacement at 19 psig for two exemplary wraps.

FIG. 13 is a graph illustrating force versus fluidic channeldisplacement at 10 psig for the two exemplary wraps of FIG. 12.

FIG. 14 is a graph illustrating water volume per surface area(Volume/Area) versus pressure for the two exemplary wraps of FIG. 12.

DETAILED DESCRIPTION

Before the present invention is described, it is to be understood thatthis invention is not intended to be limited to particular embodimentsor examples described, and as such may vary.

For convenience in explanation and accurate definition in the appendedclaims, the terms “up” or “upper”, “down” or “lower”, “inside” and“outside”, and “interior” and “peripheral” have been used to describefeatures of the present invention with reference to the positions ofsuch features as displayed in the figures. Unless expressly notedotherwise, the terms used herein are to be understood as broadly used inthe art.

In many respects the modifications of the various figures resemble thoseof preceding modifications and the same reference numerals followed byapostrophes or subscripts “a”, “b”, “c”, and “d” designate correspondingparts.

Turning to FIG. 1, a therapy wrap 30 for use in a therapy system isshown in accordance with the invention. In various respects, wrap 30 issimilar to conventional wraps such as those disclosed by U.S. Pat. No.7,198,093 and U.S. Patent Pub. No. 2005/0256556, the entire contents ofwhich are incorporated herein for all purposes.

As used herein, “wrap” is to be understood as generally used in the artof temperature-controlled therapy and broadly refers to a deviceincluding a heat exchanger alone or in combination with a variouscomponents for fastening the heat exchanger to a treatment area. Invarious respects, “wrap” refers to a device including a heat exchangerfor containing a heat exchange medium alone or with a sleeve cover. Invarious respects, “wrap” refers to the sleeve cover, fluid bladder, andcompressive element.

Various aspects of the invention are similar to the subject matterdescribed in U.S. patent application Ser. No. 09/127,256 (filed Jul. 31,1998) entitled, “Compliant Heat Exchange Panel” issued on Apr. 3, 2007as U.S. Pat. No. 7,198,093; U.S. patent application Ser. No. 09/798,261(filed Mar. 1, 2001) entitled, “Shoulder Conformal Therapy Component ofan Animate Body Heat Exchanger”; U.S. patent application Ser. No.12/910,743 (filed on Oct. 22, 2010), entitled, “Therapeutic Wrap”; U.S.patent application Ser. No. 09/901,963 (filed Jul. 10, 2001) entitled,“Compliant Heat Exchange Splint and Control Unit”; U.S. patentapplication Ser. No. 09/771,123 (filed Jan. 26, 2001) entitled,“Wrist/Hand Conformal Therapy Component of an Animate Body HeatExchanger”; U.S. patent application Ser. No. 09/771,124 (filed Jan. 26,2001) entitled, “Foot/Ankle Conformal Therapy Component of an AnimateBody Heat Exchanger”; U.S. patent application Ser. No. 09/771,125 (filedJan. 26, 2001) entitled, “Conformal Therapy Component of an Animate BodyHeat Exchanger having Adjustable Length Tongue”; U.S. patent applicationSer. No. 10/784,489 (filed Feb. 23, 2004) entitled, “Therapy Componentof an Animate Body Heat Exchanger” which is a continuation of U.S.patent application Ser. No. 09/765,082 (filed Jan. 16, 2001) entitled,“Therapy Component of an Animate Body Heat Exchanger and Method ofManufacturing such a Component” issued on Feb. 24, 2004 as U.S. Pat. No.6,695,872 which is a continuation-in-part of U.S. patent applicationSer. No. 09/493,746 (filed Jan. 28, 2000) entitled, “Cap And VestGarment Components Of An Animate Body Heat Exchanger” issued on Jan. 30,2001 as U.S. Pat. No. 6,178,562; U.S. patent application Ser. No.10/122,469 (filed Apr. 12, 2002) entitled, “Make-Break Connector ForHeat Exchanger” issued on Mar. 29, 2005 as U.S. Pat. No. 6,871,878; U.S.patent application Ser. No. 10/637,719 (filed Aug. 8, 2003) entitled,“Apparel Including a Heat Exchanger” issued on Sep. 19, 2006 as U.S.Pat. No. 7,107,629; U.S. patent application Ser. No. 12/208,240 (filedSep. 10, 2008) entitled, “Modular Apparatus for Therapy of an AnimateBody” which is a divisional of U.S. patent application Ser. No.10/848,097 (filed May 17,2004) entitled, “Modular Apparatus for Therapyof an Animate Body”; U.S. patent application Ser. No. 11/707,419 (filedFeb. 13, 2007) entitled, “Flexible Joint Wrap”; U.S. patent applicationSer. No. 11/854,352 (filed Sep. 12, 2007) entitled, “Make-BreakConnector Assembly with Opposing Latches”; and U.S. patent applicationSer. No. 10/848,097 (filed May 17, 2004) entitled “Modular Apparatus forTherapy of An Animate Body”, published on Nov. 17, 2005 as PublicationNo. 2005/0256556, the entire contents of which patents and publicationsare incorporated herein for all purposes by reference.

The above described applications and patents generally describe thermaltherapy devices, typically for cooling or heating a body part. Invarious embodiments, the device and methods of the invention areconfigured to apply therapy to a mammalian body, and preferably a humanbody. The wrap may be used on a knee, an elbow, a shoulder, a leg, ahoof, an arm, and more.

Most of the above applications and patents describe an animate bodytherapy wrap having two major components: a compliant therapy component(e.g. a liquid bladder) covering a body part to be subjected to heatexchange and a control component for producing a flowing heat exchangeliquid. Many therapy system utilize control units that produce andsupply air or other gas pressure needed to apply pressure to a body partand to press the therapy component toward a body part. This gas pressureis contained in a compliant bladder such as a gas pressure bladder. Thegas pressure bladder overlays the liquid bladder to press the liquidbladder against the body part to be subjected to heat exchange, as wellas apply compression to the body part to reduce edema. In general, thecompliant liquid bladder contains a circulating heat exchange liquid andthe gas pressure bladder overlays the liquid bladder for pressing theliquid bladder against the body part.

Turning to FIGS. 1, 5, and 6, several therapy wraps 30, 30 a, and 30 bare shown. Wrap 30 of FIG. 1 is a circumferential wrap for applying to abody part such as a knee, an elbow, an arm, or a leg of a human body.Wrap 30 b of FIG. 5 has a shape for applying to a canine. Wrap 30 c ofFIG. 6 has a shape for applying to a shoulder of a human body. In manyrespects, elements of wraps 30, 30 a, and 30 b are functionally andstructurally similar and thus will be described together.

With reference to FIGS. 1, 2, 3, and 4, therapy wrap 30 is configured toprovide temperature-controlled therapy to an anatomical body part. Thewrap includes a pair of layers 33, 35 defining a flexible fluid bladder37 through which a heated or cooled liquid is circulated. The liquid fedto the wrap is maintained at a desired inlet temperature. Generally, thedesired temperature is lower than the temperature expected for the bodypart to effectuate heat exchange. Cooling or heating of the fluid istypically achieved, at least in part, by passing the liquid through theheat exchanging medium before providing the fluid to bladder 37. Forexample, the liquid can be passed through an ice bath or a refrigerationunit. In various embodiments, the system includes a pump and controlunit, generally designated 39, for controlling one or more of thetemperature of the fluid supplied to the inlet of the fluid bladder,fluid flow rate, and fluid flow pressure. One such system is disclosed,for example, in U.S. Pat. No. 6,178,562, the entire content of which isherein incorporated for all purposes by reference.

Performance of the thermal therapy device may be improved by adjustingthe flow rate, adjusting the temperature, and/or providing additionalfeatures to the thermal therapy device. In a typical return flowarrangement, the velocity of the fluid is proportional to the flow rateinto the wrap. Keeping the inlet temperature the same, reducing the flowrate through the thermal therapy device will reduce the amount of energyremoved from (or added to) the body part requiring treatment.Conversely, increasing the flow rate will increase the amount of energyremoved from (or added to) a patient. In a cold therapy device, with thewrap applied to a mammalian body, the temperature of the fluid leavingthe wrap is warmer than the temperature of the fluid entering the wrapbecause the mammalian body is typically warmer than the thermal fluid.

As the fluid flow rate into the wrap becomes slower, the temperaturedelta increases as does the average wrap temperature. To decrease theaverage wrap temperature, the flow may be increased. A slower flow rate,however, may lead to less efficient heat transfer and other performanceproblems. Conversely, a blockage in the fluid bladder that reduces theflow rate negatively affects performance. Similarly, blockages in theflow lead to slowed or stagnant flow and “cold spots” where heattransfer is uneven, ineffective, or nonexistent. In other cases,blockages can lead to cold spots or hot spots.

As used herein, the “average temperature” of the wrap refers to theaverage of the wrap inlet temperature and the wrap outlet temperature.The difference between the wrap outlet temperature and the wrap inlettemperature will be referred to as “temperature delta” through the wrap.The temperature delta through the wrap depends on the fluid flow rate,the heat load, and the specific heat of the thermal fluid. The “maximumtemperature” and “minimum temperature” refers to the maximum and minimumtemperatures at any point in the wrap, and more specifically the fluidicchannels. In general, it is desirable to provide turbulent yet uniformflow and consistent heat transfer whereby the temperature increasebetween the inlet temperature and outlet temperature is linear, in thecase of a cold wrap.

The exemplary device 30 illustrated in FIG. 1 is a modular heat therapydevice or “wrap.” The wrap includes a first modular member or portionand one or more other modular members. The first modular member orportion comprises a heat exchanger. In the illustrated embodiment, theheat exchanger is fluid bladder 37 for circulating a heat exchangemedium such as ice water. In the illustrated embodiment, the secondmodular member comprises a gas pressure bladder 38 for applying acompressive force against the fluid bladder and treatment site.

In various embodiments, the wrap includes another modular member, sleeve41, which acts as a cover for the bladder(s). The exemplary sleeve formsa pouch into which the heat transfer device and gas pressure bladder areplaced. The sleeve is adapted to be wrapped around at least a portion ofa patient's body requiring treatment.

Various aspects of sleeve 41 are similar to those disclosed in U.S.Patent Pub. No. 2005/0256556 to Schirrmacher et al. and U.S. Pat. No.6,695,872 to Elkins, the entire contents of which are incorporatedherein for all purposes by reference. The sleeve may comprise an inneror front side portion and an outer or back side portion. The sleeve maybe formed of various materials understood in the art and may compriseinner and outer sheets of material that are sewn or fused together. Forexample, the inner and outer sides can comprise two sheets of fabricthat are sewn together to form a seam. An additional interior seam maybe provided to form a flap which is adapted to receive one or more ofthe wrap components. Suitable materials for the sleeve include, but arenot limited to, nylon, spun bonded material, hook and loop material, andmore.

In the exemplary embodiment of FIG. 4, fluid bladder 37 and gas pressurebladder 38 are contained within sleeve 41. The illustrated sleeve iscomposed of nylon on one side and a loop material (e.g. pile) on anopposite side. The exemplary sleeve also includes a fastener for holdingthe wrap device in the desired location on the animate body.Accordingly, when the device is wrapped around a portion of or theentire region being treated, the fastener holds the device in placeduring treatment. In the illustrative embodiment, a hook and loopfastener is used. If the hook and loop fastener wears out, the removablemodular bladder or sleeve can be readily replaced.

In various embodiments, the hook material portion of the hook and loopfastener comprises two sections (shown in FIG. 8). In the illustratedembodiment, each section has a length extending along the length of thestrap of about 4 or 5 inches. These sections can be spaced apart byabout 1 inch to facilitate or improve flexibility of the end portion ofthe strap. In this manner, the strap can be readily folded to providelength adjustment for differently sized users. In the illustrativeembodiment, the active areas of the hook portion of the hook and loopfastener are outside the seams forming the pouch, which can alleviateexcessive force when the wrap is under compression.

Referring to FIGS. 3 and 4, the modular bladders are positioned insidesleeve 41 in a sandwich configuration. In this state, the apparatus isready to apply to the portion of the body to be treated. In variousembodiments, the exemplary pouch formed by the sleeve allows fluidbladder 37 and gas pressure bladder 38 to move freely inside. In otherwords, beyond being confined in the pouch, there are no connectionsbetween fluid bladder and gas pressure bladder. In various embodiments,the fluid bladder and gas pressure bladder are not attached to eachother or the sleeve but are fit tightly in the sleeve to reduce anyrelative movement. The sleeve pouch thus locates the two componentsrelative to each other. This can provide a more evenly distributedcompression around the gas bladder, resulting in improved therapy of thebody being treated. In various embodiments, the fluid bladder has someroom for movement within the pouch such that there is less chance that aportion of the fluid flow is blocked when the wrap is improperly appliedto the portion of the body being treated. For example, if an unexpectedfold occurs, the fluid bladder may self-correct its position and relieveblockage of coolant flow. In various embodiments, other components maybe positioned and located within the sleeve in similar manner and aswould be understood by one of skill in the art from the descriptionherein. In the exemplary embodiment, the fluid and gas pressure bladdersare integrally formed and positioned snugly within a sleeve.

The exemplary modular members—fluid bladder 37 and gas pressure bladder38—can be readily removed from sleeve 41 so that one can clean either orboth and/or replace either component. The bladders and/or sleeve can beconstructed of a washable or reusable material. This may be helpful inapplications where the elements may need to be cleaned after beingstained with blood or otherwise soiled. In various embodiments, one orboth of fluid bladder 37 and gas pressure bladder 38 are compliant andformed of flexible material.

As used herein, “flexible” is to be understood as generally used in theart. In various respects in connection with the materials and structuresdescribed herein, “flexible” refers to tensile bending strength (i.e.can bend transversely) whereas “expandable” refers to stretching. Invarious respects, “flexible bladder” refers to a bladder that can bebent and applied to curves and contours of a body part during use.

Exemplary fluid bladder 37 includes an inlet 42, outlet 44, and at leastone fluidic channel 48 connecting the inlet and outlet. The first layer33 and middle layer 35 are joined together along a common border to formthe fluid bladder. As will be described below, a series of fences,walls, and other features define a fluid flowpath 50 between the firstand middle layers. “Treatment surface” and “treatment area” are to beunderstood as broadly used in the art. In the exemplary case, thetreatment surface generally refers to the surface in contact with theheat exchanger and the body part requiring treatment. This surface isgenerally bounded by the border and periphery of the fluid flowpath.

As used herein, “fluid flowpath” or “fluid pathway” refers to a generalpath of the fluid flow between the inlet and outlet. In a widthdirection, the flowpath is defined by adjacent features selected fromone of a wall of the bladder, a fence, a weld line, and a combination ofthe same. “Fluidic channel” refers to a channel within a flowpath formedbetween adjacent attachment points or other features.

Referring to FIG. 7 for illustrative purposes, a flowpath 50 is definedby a peripheral fence 62 adjacent a wall 60 and an interior fence 62within the fluid bladder. In turn, flowpath 50 is divided into aplurality of fluidic channels 48 by a series of attachment points. Theattachment points connect opposite walls of the bladder in a thicknessdirection (shown, e.g., in FIG. 3).

The exemplary attachment points, generally designated 65, are formed byspot welding. In various respects, the attachment points are referred toinformally as “dots.” The dots may be performed with conventionaltechniques such as RF or heat welding. The exemplary dots are circularbased on the nature of the welding process, but one will appreciate thatthe dots may have different shapes.

“Attachment point” is to be understood as used in the art and generallyrefers to points that are essentially one-dimensional as opposed tolines, shapes, and other similar features. The dots are similar in manyrespects to fences except that they are single points rather than ashape or line.

In some respects, “fluidic channel” may refer to the entire flowpathfrom wall-to-wall in a width direction or any sub-unit within theflowpath depending in part on the use and position of fences and dots.

In various embodiments, the fluid bladder and gas pressure bladder areintegrally formed. In various embodiments, fluid bladder 37 and gaspressure bladder 38 form separate chambers positioned adjacent eachother. In various embodiments, the chambers are generally parallel toone another and are made so as to preclude fluid communication betweenthe two during use.

Exemplary gas pressure bladder 38 is formed by joining middle layer 35to a second layer 36 on an opposite side of the middle layer from firstlayer 33. Thus, exemplary bladders 37 and 38 are formed from threesheets of material joined along a common border (e.g. wall 60). The gaspressure bladder includes a single port 52 for regulating gas in and outof the bladder.

In an exemplary embodiment, all layers 33, 35, and 36 are formed ofpolyurethane with nylon. Suitable materials for the fluid bladder andgas pressure bladder include, but are not limited to urethane, polyvinylchloride (PVC), polyurethane (PU), nylon, and more. In variousembodiments, the fluid bladder and gas pressure bladder are made of aflexible plastic.

Referring to FIGS. 1-4, inlet 42, outlet 44, and port 52 are housedwithin or connected to a single, quick-connect plug or manifold 54. Eachexemplary port is formed by a tubular member, which has one end adaptedto receive a hose connector and another end adapted to be inserted intoone of three tubes extending from the bladder as is known in the art.The hose connector connects the bladders to a hose that in turn connectsto pump and control unit 39.

In various embodiments, one or more of the manifold fluid inlet 42 andoutlet 44 includes a valve configured to allow the passage of fluidtherethrough when the fluid hose connectors are coupled to the manifoldand to prevent fluid flow therethrough when the fluid hose connectorsare uncoupled. Suitable valves known in the art may be used such as apoppet or check valve. The exemplary inlet and outlet include aspring-loaded poppet valve. In this manner, fluid such as a liquidcoolant is blocked from exiting fluid bladder 37 when the fluid hosesare uncoupled from the manifold. The exemplary gas port does not includea valve.

In various embodiments, fluid bladder 37 is adapted to receive andcirculate a fluid, such as a coolant, which can be in the form of a coldliquid, to transfer heat away from the animate body part. Alternatively,the fluid supplied to fluid bladder can have a temperature higher thanthe body so as to heat the animate body part.

Gas pressure bladder 38 is adapted to receive a gas (e.g. air), whichcan be regulated to provide the desired amount of inflation of thebladder or pressure therein. This inflation or pressure affects thecompressive force applied to the fluid body, and consequently theanimate body, during use. Specifically, the gas pressure bladderoverlays the fluid bladder as illustrated in FIG. 4 such that the gaspressure bladder directs gas pressure against the fluid bladder to pressit towards the portion of the body being treated. In variousembodiments, the gas pressure bladder is inflated to a pressure between0 psig and about 5 psig, preferably between about 0.2 psig and about 3psig, and more preferably between about 0.25 psig and about 1.5 psig. Invarious embodiments, the gas pressure bladder is inflated to a pressureabove 5 psig. In general, the gas pressure bladder is enclosed betweensleeve 41 and fluid bladder 37. Thus, the pressure of the gas pressurebladder is directed to the fluid bladder, which in turn compresses thebody part.

One will also appreciate that the compressive gas pressure is also basedon the middle layer which forms a common wall with the fluid bladder andgas pressure bladder. In other words, the middle layer may be configuredto adjust the compressive force. As will be apparent from FIG. 4, forexample, a more rigid middle material may adjust the balance between thepressure in the expanded fluidic channels and gas pressure bladder. Theshape of the fluidic channels will also change. In various embodiments,the flexible material forming the middle layer is selected based on thedesired compressive pressure.

In various embodiments, the gas pressure bladder is at a lower pressurethan the fluid bladder. In an exemplary embodiment, sleeve 41 holds wrap30 taut against the body part requiring treatment. Accordingly, aspressure is applied to gas pressure bladder 38, it has little room tomove and the pressure is directed primarily against the fluid bladder.Thus, even low pressures in the gas pressure bladder accumulate pressureon the fluid bladder.

One will appreciate from the description herein that the material typeand content may be modified based on the intended operational parametersand desired filling of the fluid bladder and gas pressure bladder.Moreover, one will appreciate that material selection and theconfiguration of the middle layer may be modified depending on thedesired interaction between the gas pressure bladder and fluid bladder.For example, a stiffer middle layer may be used to distribute pressurefrom the gas pressure bladder to the fluid bladder more uniformly. Themiddle layer and outer second layer also may be selected and configuredto control the amount of “ballooning” of the gas pressure bladder oneach side.

Exemplary wrap 30 includes a plurality of fences 62 and dot connections65. More specifically, and with particular reference to FIGS. 2, 3, and4, a plurality of connections between walls 60 defining fluid bladder 37or gas pressure bladder 38 can be provided. The connections and theirmethod of manufacture are similar in some respects to those disclosed byU.S. Pat. No. 6,695,872 to Elkins and U.S. Pat. No. 4,149,541 to Gammonset al., the entire contents of which patents are hereby incorporatedherein for all purposes by reference. Such connections can minimize oreliminate undesirable ballooning when the fluid and/or gas pressurebladder is pressurized. In the illustrative embodiment, in which thebladders are formed by RF welding (see, e.g., FIGS. 10A, 10B, and 10C),reduction of ballooning is achieved by forming some of the interiorconnections in the fluid bladder while the materials 33 and 35 are inplace as will be described in more detail below. Other connections, suchas the peripheral border and fence, are formed while the materials 36and 35 are in place. The result is that many of the connections extendthrough the fluid bladder and gas pressure bladder.

The shape of exemplary gas pressure bladder 38 conforms to the shape ofexemplary fluid bladder 37. Fences or dividers 62 in the fluid bladderare configured to direct fluid flow in the fluid bladder and can also beprovided in the gas pressure bladder. These control fences can beprovided not only for the purpose of directing the flow of a liquid orgas but also to secure the walls defining the bladder together atvarious locations within the interior of such bladder. As describedabove, these connections can prevent the bladder from “ballooning”thereby preventing the wrap from conforming to the body part. In theillustrated embodiment, most or all of the fences in the gas pressurebladder register with the comparable fences in the fluid bladder.

Although adding connections provides the above benefits, an excessivelylarge number of connections can increase the risk of kinking. As thewelds takes up a larger percentage of the treatment surface, thematerial becomes stiffer. At a certain level, the bladder becomes sostiff as to be difficult to conform to a body part. As discussed above,a greater number of connections also reduces the amount of shearing andmovement between the material layers. Accordingly, various aspects ofthe invention are directed to the careful configuration of dot spacing,size, and shape to provide a wrap with good fluid circulation whilereducing the risk of kinking.

With continued reference to FIGS. 1, 2, 3, and 4, wrap 30 includes areinforced portion to increase the wrap's kink resistance in accordancewith various aspects of the invention. In various embodiments, the wrapincludes selective reinforcement. In various respects, “selectivelyreinforced” generally refers to providing reinforcement in specific,targeted locations relative to the remainder of the wrap. In variousrespects, “selectively reinforced” generally refers to providing avariable amount of reinforcement along the wrap surface. “Reinforcement”and “reinforced” are to be understood as generally used in the art andmay refer to modifications and configurations of existing elementsand/or the addition of distinct members to provide reinforcement and/orincrease strength. As will be described below, the reinforcement may beprovided in the way of external structural members with increasedstructural rigidity or a different configuration of the same materialsto resist kinking and/or bending.

A technique for selective reinforcement of the wrap by adjusting the dotconnections will be described with reference generally to FIGS. 1-7. Awrap in accordance with the invention may include a selectivereinforcement region corresponding to a kink-prone region. As usedherein, “kink-prone region” generally refers to a region presentingconditions conducive to kinking absent the techniques described herein.“Kink-resistant zone” and “reinforcement region” generally refer to azone or local region of the device configured to counteract suchconditions. In various respects, “kink-prone region” and “kink-resistantzone” are used interchangeably. Functionally, kink resistance may beexpressed in terms of increased tensile or bending strength, or adecreased minimum bend radius.

As illustrated, for example, by the wrap in FIG. 1, the kink-proneregion may correspond to the body part to which the wrap is applied. Thewrap shown in FIG. 1 is a circumferential wrap which may be applied toan anatomical joint such an elbow or knee. With a conventional wrapconfiguration, the fluid bladder risks bunching and forming “wrinkles”with tight radiuses when the joint is flexed. Along the back of theknee, conventional wraps tend to collapse because the void formed by theback of the knee removes any support of the fluid bladder against thecompressive air bladder. The exemplary wrap of FIG. 1 incorporatesseveral of the features described herein to overcome these and otherdrawbacks of conventional wraps.

Exemplary wrap 30 includes a reinforcement region having a plurality offences and dots in a special configuration to increase resistance tobending or kinking. A portion of the interior of the fluid bladder 37away from kinking features include a relatively uniform distribution ofdot connections 65, referred to in some respects as an “open area” or“open field” and generally designated 70. In some respects, “open area”or “open field” are to be understood as generally used in the art andrefers to a portion of the flowpath away from a region that is subjectedto folding. In various respects, “open area” refers to a portion of thewrap that does not undergo bending near or beyond a kink radius of thebladder during normal use. The exemplary bladder also includes aselectively reinforced pattern of dot connections configured to resistkinking in other portions of the bladder referred to as kink-resistantzones, generally designated 73.

A traditional method for reducing the likelihood of kinking is to makethe entire bladder more rigid (e.g. assembling from more rigidmaterials) or avoid bending of the structure beyond the kink radius,also referred to as the minimum bend radius. By contrast, the internalstructure of the selectively reinforced fluid bladder of FIG. 1 ismodified to decrease the kink radius in the bending region, strengthenthe material to limit the local amount of bending, or both. In variousembodiments, the kink radius of the local kink-resistant zone is about 5mm or less. In various embodiments, the entire wrap has a kink radius ofabout 5 mm or less. In various embodiments, the kink radius of thekink-resistant zone is at least 10% smaller than the kink radius of anyother remaining portion of the wrap, and more preferably at least 25%,at least 50%, or at least 75% smaller.

As shown in FIG. 7, a series of adjacent dots 65 form an imaginary line.Dots in alignment form a straight line as denoted by line “A” in FIG. 7.On the contrary, dots in an irregular or random pattern form a crooked,non-linear line, at best. In the exemplary wraps of FIGS. 1-7, dots inan open area have a regular pattern that form crossing imaginary linesas described, for example, in U.S. Pat. No. 6,695,872, incorporatedherein for all purposes by reference. In the kink-resistant zones,however, the dots are positioned to avoid forming a straight line asdenoted by line “B” in FIG. 7.

It has been found that some kinking tends to occur near an apex orcorner of flaps of the fluid bladder (represented, e.g., as “X” in FIG.5). In various embodiments, the dots are aligned to direct bendingstress away from high stress areas. In various embodiments, the dots arealigned to limit stress concentrations in the kink-resistant zone. Asthe flap is folded, the material wants to form along a so-called “hingeline” between the weakest points, in the exemplary case, two cornersdepicted by line “C” in FIG. 7. Accordingly, the selectively reinforceddot pattern may be positioned to form a line of weakness to directbending stress away from the apexes and into an open field where thematerial has more room to bunch up.

In various embodiments, the dots in a kink-resistant zone are aligned ina pattern to form an imaginary line orthogonal to a local fence or wall.In various embodiments, the dots are positioned to control bending alonga line at an obtuse angle to the fluid flow. In various embodiments, thedots in a kink-resistant zone are positioned without any lineararrangement. In other words, the dots form an imaginary line that isnon-linear. As shown, for example, in FIG. 7, non-linear line “B” iscrooked and does not extend in any single direction.

In various embodiments, the selectively reinforced dot pattern isaligned over a fluidic channel and/or fluid flowpath. In variousembodiments, the selectively reinforced dot pattern is positionedentirely within a fluid flowpath. In various embodiments, theselectively reinforced dot pattern overlaps two or more fluid flowpaths.

Referring to FIGS. 2 and 7, dots 65 may have various positions andconfigurations. In various embodiments, the dots have differentdiameters. In various embodiments, the average dot diameter is larger ina local region of bending than in open areas. In various embodiments,the dot diameter is variable. As shown in FIG. 2, the dot diameter maygenerally decrease moving in a direction away from a local fence or walland towards an interior of the bladder. In various embodiments, the dotdiameter generally decreases moving in a direction from a fluid pathwaywall towards a middle of the pathway. In various embodiments, the localspacing between dots is proportional to the diameter of the dots. Invarious embodiments, the spacing between the dots generally increases asthe diameter of the dots decreases. These and other configurations mayfurther act to preferentially reduce stress concentrations and increasekink resistance.

Reiterating the description above and with reference to FIGS. 1-4,exemplary fluid flowpath 50 is defined by a space between first outerlayer 33 and middle layer 35 on a top and bottom and walls 60 and fences62 on each side. Within the flowpath, attachment points (dots) 65further define a plurality of fluidic channels 48. As shown in FIG. 4,the fluidic channel is surrounded by materials 33 and 35. The attachmentpoints pinch shut the bladder to form the fluidic channel. As shown inFIGS. 3 and 4, the width of the fluid pathway thus comprises alternatingfluidic channels and weld spots. Accordingly, the fluidic channeldimension is based on the location of the dots. The dimensions are alsoa function, to an extent, of the elasticity of the materials 33 and 35and pressure in the respective channel. In various embodiments, thesecond outer layer 36 and middle layer 35 are formed of a material thatis relatively resistant to stretching, for example, on the order ofmillimeters of stretching over the entire length of the wrap.

Conventionally, dots were added to bladders and expandable fluidchambers to reduce the effects of “ballooning.” The dots also tended tobe distributed across the bladder in a somewhat uniform and proportionalmanner based on a simple view of cost and manufacturability. Forexample, previously the dot diameter could be based on tooling costs andoverall bladder size. The dot configuration in accordance with thepresent invention, by contrast, generally reduces the occurrence failuremodes while maintaining or improving performance. In various respects,the dot configuration takes into account several performance andoperational concerns in addition to manufacturing concerns.

As discussed above, the dot configuration may be important to increasingkink resistance while maintaining effective heat exchange performance.Several considerations are taken into account in selecting the dotspacing, size, and other factors. In general, the various factors mustbe within a specific range to achieve optimum performance. By example,it is understood that increasing the dot size can provide a strongerweld, but it has been found that increasing the size above a certainlevel decreases performance because the bladder becomes too rigid. Inpart, it is believed that the bladder becomes too rigid to conform andcompress around the body part. Similarly, decreasing the weld size mayreduce kinking at the expense of weld strength. Accordingly, the dotconfiguration described below involves the careful and complex balancingof many factors.

FIG. 4 is a representative sketch of a typical series of fluidicchannels and gas pressure channel in a kink-resistant zone. As shown inFIG. 4, a first fluidic channel has a width “d1” and height “h1” whenfilled with fluid. A second fluidic channel has a width “d2” and height“h2”. The diameter of dots 65 are represented as widths “D1” and “D2” inthe figure. Likewise, the cross-sectional area of each fluidic channelis based on d and h. As used herein, “average” refers to an averagewithin a local reference area. For example, an average dot diameter inthe exemplary view of FIG. 4 is the average of D1 and D2.

In various embodiments, d1 and d2 are essentially equal. In variousembodiments, d1 and d2 are different. In various embodiments, D1 and D2are essentially equal. In various embodiments, D1 and D2 are different.

In various embodiments, h is variable through the kink-resistant zone,open areas, or both. In various embodiments, H is variable through thekink-resistant zone, open areas, or both. In various embodiments, h isabout 0.1 inch, and more preferably 0.175 inch.

In an exemplary embodiment, the dots have an average diameter betweenabout 0.05 inch and about 0.2 inch in open areas. In an exemplaryembodiment, the dots have an average diameter of about 0.09 inch in openareas. In various embodiments, the average diameter is larger in aselected kink-resistant zone than in open areas.

In various embodiments, the dots in the kink-resistant zone have adiameter in a range of between about 0.15 inch and about 0.4 inch,preferably between about 0.15 inch and about 0.35 inch, more preferablybetween about .15 inch and about 0.2 inch, and more preferably betweenabout 0.16 inch and about 0.2 inch. In various embodiments, the dots inthe kink-resistant zone have an average diameter of about 0.15 inch. Bycomparison, conventional wraps typically have a smaller or larger dotdiameter. One example of a conventional wrap includes a fluid bladderwith dots have an average diameter of about 0.5 inch.

The dots may be formed from a conventional tool. In various embodiments,the dots in the kink-resistant zone are formed from a tool die that hasa diameter of about 0.093 inch. In various embodiments, the tool diediameter is about 0.09 inch. In various embodiments, the tool diediameter is in the range of between about 0.05 and about 0.25 inch.

In various embodiments, the welding parameters are varied to achieve adot diameter of between about 0.15 inch to about 0.2 inch. In variousembodiments, the dots in the kink-prone region and open areas are formedby the same tool but with different processing conditions. For example,the same tool can be used across the entire wrap but the weldtemperature and/or time may be increased in the kink-resistant zone toproduce larger dots.

In various embodiments, the dot connections in the kink-resistant zoneare positioned and configured to maintain the average fluidic channelcross-sectional area above a predetermined threshold. In variousembodiments, the dot connections in the kink-resistant zone arepositioned and configured to maintain the cross-sectional area of eachof the fluidic channels above a predetermined threshold. In variousembodiments, the dot connections in the kink-resistant zone arepositioned and configured to maintain the average fluidic channelcross-sectional area below an upper predetermined threshold. In variousembodiments, the cross-sectional area of the fluidic channels in thekink-resistant zone is about 0.02 sq.-in, and more preferably 0.0254sq.-in.

At a certain fluidic channel volume, the performance of the wrap isnegatively affected. For example, an excessively large cross-sectionalarea of the fluidic channels (such as by providing a very high “h”value, “d” value, or both) leads to high fluid volume in the wrap. Whenthe volume is too high, the heat exchange fluid takes undesirably longto circulate through the wrap and becomes difficult to maintain toprovide effective therapy even when adjusting the inlet temperature. Forexample, it has been found that a fluid bladder having a fluid volume of4000 mL/m² exhibits poor heat exchange performance compared to theexemplary wrap 30. Also, at such large fluid volumes the wrap loses theability to conform to a complex shape at higher pressures. In theexample above of a bladder with 4000 mL/m², the pressure typically mustbe low, in the range of 5 psi to maintain flexibility. At low pressures,however, heat exchange is decreased and the time to circulate fluidthrough the wrap is increased significantly. By contrast, the exemplarywrap allows for smaller fluidic channels without the risk of buckling ofthe channels at water volume levels having good operational performance.

In various embodiments, the cross-sectional area of the fluidic channelsin the kink-resistant zone is in a range between about 10 mm² to about40 mm², preferably about 15 mm² to about 25 mm².

In various embodiments, the distribution of dot connections is variedacross the fluid bladder to achieve kink resistance in selected areas.For example, as shown in FIG. 6 described below, the distribution ofdots in the kink-resistant zone is lower than in the open areas. In thismanner, the fluidic channels have a larger cross-sectional area in thekink-resistant zone to reduce the risk of occlusion and/or increase therestoring force from the fluid in the channel.

It has been found that the total fluid volume relative to the treatmentarea of the fluid bladder can be important in certain applications. Thisratio may be referred to in terms of total volume of the fluid bladderin liters relative to a flat treatment surface area of the bladder insquare meters. In various embodiments, this fluid volume/treatment arearatio at about 10 psi is between about 1000 mL/m² and about 2000 mL/m²,preferably between about 1000 mL/m² and about 1500 mL/m², and morepreferably between about 1200 mL/m² and about 1500 mL/m². By contrast,conventional fluid bladders typically have a low fluid volume relativeto the treatment area or a very high fluid volume relative to thetreatment area. In one example of a conventional liquid bladder, thefluid volume/treatment area ratio is well below 1000 mL/m² at 10 psi,and in one example, 800 mL/m². In another conventional example, thefluid volume/treatment area ratio is over nearly 3000 mL/m² at 5 psi,nearly 4000 mL/m² at 10 psi and nearly 4500 mL/m² at 15 psi. Moreover,because conventional liquid bladders aim to have generally uniform dotconnection distributions (and likewise fluid channel size), conventionalbladders fail to realize the many benefits of selective reinforcementdescribed herein even if the total fluid volume is changed.

As explained above, the fluidic channel width informs thecross-sectional area of the fluidic channel, which affects flow rate,pressure, and other parameters. In an exemplary case utilizing dotpatterns, the channel width is based on the positioning and spacing ofdots. One will appreciate that even small changes in the dot spacing anddiameter can have large affects on the fluid flow. For example, even ifthe height remains the same, a small change in the fluidic channel widthhas a relative large affect when multiplied by the number of fluidicchannels. Thus, the dot spacing and dot diameter may be critical tooptimizing performance.

As explained above, the edge-to-edge spacing of the dots (e.g. d1 inFIG. 4) generally corresponds to the fluidic channel width. In variousembodiments, the average edge-to-edge spacing between adjacent dots in akink-resistant zone is between about 0.35 inch and about 0.75 inch,preferably between about 0.35 inch and about 0.5 inch, and morepreferably 0.425 inch. In various embodiments, the average edge-to-edgespacing between dots in a kink-resistant zone is 0.235 inch. In variousembodiments, the average center-to-center spacing between dots in akink-resistant zone is between about 0.15 inch and about 0.5 inch,preferably about 0.2 inch and about 0.5 inch, more preferably betweenabout 0.2 inch and about 0.25 inch, and more preferably about 0.155inch. In various embodiments, average spacing between dots in theremainder of the fluid bladder aside from the kink-resistant zone isless than about 0.35 inch, and preferably about 0.33 inch.

As used herein, “adjacent dots” generally refers to dots immediatelyadjacent one another. The dots may be oriented laterally orlongitudinally (e.g. FIG. 4) or diagonally. In various respects,“spacing” refers to the minimum distance between the dots.

In summary, the exemplary wrap of FIG. 1 is configured to reduce oreliminate kinking during use. The exemplary wrap provides akink-resistant zone wherein the regular pattern of attachment points isinterrupted. In the open areas of the fluid bladder, attachment pointsmay be formed as disclosed by U.S. Pat. No. 6,695,872 to Elkins. In theElkins wrap, the matrix of connections, attachment points andcurvilinear fences, acts to disperse the liquid throughout the bladderand redirect the flow of a liquid as necessary. In various embodiments,the same principles are used to guide the design of dot connections inthe open areas of wrap 30. In various embodiments, the exemplary wrap 30has dots formed in a triangular grid in open areas 70.

By contrast, the exemplary wrap has a dot configuration to increase kinkresistance in kink prone regions. In various embodiments, the attachmentpoints of wrap 30 have an irregular pattern and configuration in a kinkresistant zone. In this kink-resistant zone, the attachment points arearranged differently than in the remainder of the wrap. The exemplarywrap is reinforced by dimensioning, positioning, and configuring theattachment points to resist kinking in the selected local zone(s) asdescribed herein. Any of the above ranges—dot diameter, dot spacing,volume/surface ratio, and the like—may be used in any combination inaccordance with the invention.

The reinforced wrap in accordance with the above provides severaladvantages over conventional wraps with dot patterns. For one, the wrapmay realize the advantages of a uniform distribution of dots in openareas (e.g. effective redirection of fluid flow) while reducing the riskof kinking in selected areas. The selective distribution andconfiguration of dot connections may increase flow in open areas whilemaintaining efficient flow in kink-prone areas even when placed incompression and/or bent. The wrap in accordance with the invention mayalso have improved fluid circulation and performance. Specifically, thewrap may avoid undesirable cold spots, negative flow turbulence, and/orfluid blockages in comparison to existing wraps.

An exemplary use of a modular therapy apparatus in accordance with theinvention will now be described with reference to FIG. 1. This exampleis provided for illustration and is not intended to limit the scope ofthe invention. Exemplary wrap 30 is shown in the open state in FIG. 1.The open wrap is positioned adjacent a portion of a human patient's legrequiring treatment. The exemplary wrap includes a fastener so the wrapcan be rolled and coupled around the leg in a manner similar to thatdescribed in U.S. Patent Pub. No. 2005/0256556, the entire contents ofwhich are incorporated herein for all purposes by reference.

The wrap is then connected to control unit 39. The exemplary controlunit includes a mechanism for cooling and circulating a liquid coolant.The exemplary control unit includes a fluid reservoir for containing icewater and a pump. In a practical realization of this embodiment, theliquid is cooled tap water and the gas provided to gas pressure bladder38 is air. The liquid for fluid bladder 37 is cooled by placing ice intoan ice box portion of the control unit, resulting in temperaturesranging typically between about 32° F. and about 50° F. In variousembodiments, the liquid is supplied to the fluid bladder at a pressurein the range between about 5 psi and about 20 psi, between about 10 psiand about 20 psi, between about 15 psi and about 20 psi, or at anaverage of about 19 psig.

The user turns on the control unit and selects desired settings tocirculate fluid to fluid bladder 37. In the exemplary case, the controlunit receives and recirculates liquid returned from the fluid bladder.The control unit is also capable of controlling the temperature of theliquid to the fluid bladder.

The exemplary control unit also includes an air pump and controller. Airis pumped into gas pressure bladder 38 and the pressure in the bladderis controlled by the control unit thereby regulating compressivepressure on the fluid bladder. The pressure of air furnished by thecontrol unit is generally between about 0 to about 2 psig, andpreferably between about 0.25 to about 1.5 psig. As a result of theexemplary selective reinforcement dot pattern, the wrap can operate atlower fluid volumes, lower fluid pressure, and/or increased compressiveforce without a commensurate risk of kinking.

It should be noted that the invention is applicable to many other typesof therapy components, and the particular liquid, its temperature, andpressure will be dependent upon the design and purpose of such therapycomponents. This is also true of the air pressure, and in someinstances, it is cycled between two pressures.

Typically, the treatment area of the wrap will range from about 0.15sq.-feet to about 6 sq.-feet. In the case of a knee application asdescribed above, this area will be about 3 sq.-feet. In the case of anelbow, this area will be about 1 sq.-feet to 1.5 sq.-feet. In turn, onewill appreciate from the description herein that the size and shape ofthe treatment area and fluid pathway influence the desired inlettemperature and flow rate settings, among other settings.

FIGS. 5 and 6 illustrate wraps and constituent components having variousshapes to accommodate different animate body contours. FIG. 5illustrates a wrap 30 b configured for applying to a body of a canine.Wrap 30 b is similar in many respects to wrap 30 described above exceptthat the fluid bladder, gas pressure bladder, and sleeve have a shape toaccommodate a canine body or body part. The peripheral border ismodified to enable wrapping to the body, in the exemplary case afour-flap, cloverleaf-type shape. Each of the flaps are shaped to wraparound the canine body part.

Wrap 30 b includes a dot matrix similar to wrap 30 described above. Afence 62 b extends through a central interior of the wrap to define afluid pathway that snakes around the periphery of the wrap. A peripheralfence 62 b′ extends around the wrap border. Both fences have a generallycurvilinear shape. As shown in FIG. 5, dots 65 b cover the entire fluidbladder.

Unlike wrap 30, however, wrap 30 b has a considerably smaller area andthus does not have any significant and discernible open areas. For thisreason, the dots are configured to form a selectively reinforced regionthat comprises a large portion or all of the fluid bladder. Inparticular, the kink-prone regions generally are located around theslits defining adjacent edges of the flaps, and especially the apex ofthe slits positioned inward of the border.

As will be understood from the figure and description above, a wrap mayhave several kink-prone regions having different relative levels of riskof kinking. The central region 62 b of the exemplary wrap is especiallyprone to kinking because the material width is narrowed and subject toconsiderable bending, referred to as a “necking” region. The amount ofarea to accommodate bending in the central region is also divided byfence 62 b. The central region also tends to undergo twisting andbending in more than one direction. The material adjacent the flap edgesbut further towards the outer periphery, however, generally has a lowerrelative propensity to kink.

As shown in FIG. 5, the dots in the central region have a skewed patternthat avoids or reduces the probability of hinge lines forming near thecenter, generally designated 81, which is a high stress concentrationarea. Instead, stresses that build during bending find their way alongdots away from the narrowed central region.

In various embodiments, the selectively reinforced dot pattern isconfigured to increase the local tensile strength by at least about 10%,and more preferably at least about 20%, at least about 50%, at leastabout 75%, at least about 100%, or at least about 150%. In variousembodiments, the selectively reinforced dot pattern is configured toincrease resistance to kinking by at least about 10%, and morepreferably at least about 20%, at least about 50%, or at least about75%, at least about 100%, or at least about 150%. In various respects,resistance to kinking refers to the occurrence of measurable kinking orkink failure during use. In various embodiments, the selectivelyreinforced dot pattern is configured to reduce the risk of kinking by atleast about 10%, and more preferably at least about 20%, at least about50%, or at least about 75%.

FIGS. 6 and 7 illustrates a wrap 30 c configured for applying to ahuman. Wrap 30 c is similar in many respects to wrap 30 described aboveexcept that the fluid bladder, gas pressure bladder, and sleeve have ashape to accommodate application on a human shoulder. Accordingly, thewrap has a more complex shape.

FIG. 7 is an enlarged detail view of one of the primary regionsotherwise prone to kinking. As discussed above, for purposes ofillustration of the principles herein, exemplary wrap 30 c includes aseries of dots in this region, some of which have conventionalpositioning (e.g. line “A”) and some of which have positioning to reducethe likelihood of kinking (e.g. line “B”). Line “C” illustrates thenatural hinge line determined by the shape of the wrap. The exemplarynon-linear positioning of the dots of line “B”, reduces the likelihoodof bending focusing along line “B”. Instead, the bending stress willfind a path along dots that are directed towards an open area. Bycontrast, bending is likely to occur along linear line “A”.

FIG. 8 illustrates another wrap 30 d in accordance with aspects of theinvention. Wrap 30 d is similar in many respects to wrap 30 except thatwrap 30 d includes a separate and distinct structural member to provideselective reinforcement instead of a variation in the weld pattern,materials, and the like.

Wrap 30 d includes a fluid bladder 37 d and one or more reinforcementmembers 101. The fluid bladder includes an inlet 42 d and outlet 44 d. Aheat exchanging fluid from a reservoir is introduced to the bladderthrough the inlet, typically using a pump. Exemplary outlet 44 isconnected to the reservoir so fluid is returned and recirculated.

In various embodiments, reinforcement member 101 is attached to a sideof the fluid bladder opposite from the bladder's treatment side. In anexemplary embodiment, reinforcement member 101 is positioned betweenfluid bladder 37 and gas pressure bladder 38. The reinforcement membermay be integrated with or attached to one side of middle layer 35(shown, e.g., in FIG. 3). In an exemplary embodiment, the reinforcementmember is attached to a gas side of the middle layer and actuallydisposed within what becomes the gas pressure bladder. In variousembodiments, the reinforcement member is carried by a substrate in areinforcement layer. The optional reinforcement layer is assembledwithin the wrap similar to the first, middle, and second layers.

FIG. 3 shows an exemplary positioning of reinforcement member 101. Inthe exemplary wrap of FIG. 3, a reinforcement member is positionedwithin gas pressure bladder 38. In the exemplary configuration, if thegas pressure bladder is collapsed, the reinforcement member will beplaced in compression and prevent total closure of the gas channel.Instead, the edges of the reinforcement member will retain some spacefor the gas to flow through the bladder thus preventing total blockage.The reinforcement member may be carried on a substrate that has a widthcorresponding to the pressure bladder to enable relative positioning ofthe reinforcement member in the bladder.

FIG. 8 illustrates a wrap 30 d with several kink-resistant zones 73 dincluding separate reinforcement members 101. The exemplaryreinforcement members have elongated shapes and are essentially alignedwith a direction of flow. One of the reinforcement members isessentially straight. The others have an irregular shape with curves,corners, and the like.

The reinforcement members may have a variety of shapes and sizes. Theexemplary reinforcement members 101 are substantially planar tofacilitate attaching to the fluid bladder and maintain a lower profileof the wrap. The thin shape may also reduce wrinkling in the wrap.However, one will appreciate that the reinforcement members may have athree-dimensional shape with a thickness such as a rod, a bar, a box,and more.

The reinforcement members 101 generally impart increased strength to thelocal region where they are positioned. In various embodiments, thereinforcement members have a bending stiffness or tensile strength atleast an order of magnitude higher than the fluid bladder. In variousembodiments, the reinforcement members are configured to increase thelocal tensile strength of the resulting wrap by at least about 10%, andmore preferably at least about 20%, at least about 50%, at least about75%, at least about 100%, or at least about 150%. In an exemplaryembodiment, the reinforcement member has a significantly higher hardness(durometer) than the sleeve, fluid bladder, and/or gas pressure bladder.In an exemplary embodiment, the sleeve comprises nylon with a skim coator vapor barrier and the fluid and gas pressure bladder compriseurethane with a stiffener (e.g. nylon). In turn, the exemplaryreinforcement member has an increased thickness, higher materialstrength, or both. In an exemplary embodiment, the reinforcement memberhas a thickness comparable to the bladder materials and is formed of ahigh nylon content material.

In various embodiments, the wrap includes a reinforced dot pattern and adiscrete reinforcement member. A region of the reinforced dot patternmay be positioned in various ways with respect to the one or morereinforcement members. The reinforced dot pattern region may be largerthan the reinforcement member, the same size, or smaller. The reinforceddot pattern region may overlap the reinforcement member. Thereinforcement member may overlap the reinforced dot pattern region. Thereinforcement member and reinforced dot pattern may be aligned andpositioned in the same region.

In various embodiments, the chambers of the fluid bladder and gaspressure bladder comprise primarily flexible materials and thereinforcement member is a formed of a rigid material. The exemplary wrap30 d includes a sleeve formed of flexible nylon loop material, a fluidbladder and gas pressure bladder formed of polyurethane-based materials,and a reinforcement member formed of metal. Suitable materials for thereinforcement member include, but are not limited to, metals, alloys,thermoplastics, ceramics, shape memory materials (e.g. nickel titanium),open cell foam, “scrubby pad”, and more.

In some respects, the reinforcement members may be similar in shape,structure, and overall design to reinforcements in other fields. Forexample, the reinforcement member may have a waffle shape, I-beam shape,or cross-beam to achieve the desired amount of structural strength.

In various embodiments, the reinforcement member is shaped andconfigured based on the anatomy of the body part. For example, in thecase of a knee wrap, the reinforcement member may have a curved shape tobetter conform to the knee when bent. In this case, the curve may havean arc angle to allow bending to a predetermined angle but resistfurther local bending, for example, past a minimum bend radius (kinkradius). In the example of a knee wrap, a reinforcement memberpositioned around the knee may be used to promote a more uniform bend orcurve and prevent wrinkle-type kinks.

In various embodiments, reinforcement member 101 is a batten. The battenmay be flexible in one direction of bending and rigid in anotherdirection. In another embodiment, the reinforcement member is anadhesive. In this case, the fluid bladder is bonded to another memberhave a high tensile strength in a manner that prevents shearing of onemember relative to another thereby resisting bending. In other words, asthe flexible bladder is bent, the other material counteracts the bendingforce of the inner bladder material as it is pulled in tension andlimits the bend radius. The reinforcement member may be one or more of abatten, a weakened section or line, an exoskeleton, a ribbon, a tubularmember, a helical member, a spring, a bar linkage, and the like. In theexample of an exoskeleton, the reinforcement member may include a rigidframe or skeletal structural to increase the rigidity and/or bendingstrength of the selected region in which it is placed. The member may beshaped so it is positioned around the dots in the bladder. Thus, thereinforcement member may be placed in the mold before forming the dotsand fences. One of skill in the art will appreciate from the descriptionherein the manner for selecting materials and configuring thereinforcement member to achieve the desired level of reinforcement.

In the exemplary embodiment, each of reinforcement members 101 ispositioned entirely within or along a fluidic channel 48 d. The members,however, may also overlap multiple channels. This may be desirable wherethe kink-prone region relates to a feature that risks kinking inmultiple fluidic channels or fluid pathways. For example, in the case ofa knee wrap, the apex of the bend corresponding to the knee cap mayoverlap multiple fluid pathways.

FIG. 9 illustrates a wrap 30 e configured and constructed similar to thewrap 30 d described above and shown in FIG. 8. Wrap 30 e includes fourreinforcement members 101.

The exemplary reinforcement members are strips welded or bonded to thegas pressure bladder. The exemplary strips comprise stiffened urethane.The exemplary reinforcement members have essentially the same bendingstrength, but one will appreciate that they may have differentstrengths. Moreover, each reinforcement member may have a different orvariable bending strength along its length.

Each of the exemplary reinforcement members spans the entire width ofthe wrap from border-to-border and is generally aligned within a lateralfluid flowpath 50. Likewise, the reinforcement members are parallel tothe direction of wrapping. Alternatively, the reinforcement members mayhave a serpentine shape that corresponds to the serpentine fluidflowpath. The exemplary wrap is designed to wrap around a straight bodypart like a leg. When the wrap is fastened to the body part, thereinforcement members form circular rings around the body part.Accordingly, the reinforcement members selectively reinforce theflowpath and resist bending in a transverse direction to the flowpath.Similarly, the reinforcement members may be configured to resist bending(increase tensile strength) in one or two bending directions but not inthe other directions.

In operation and use, wraps 30 d and 30 e of FIGS. 8 and 9 havingreinforcement members are used in a similar manner to wrap 30 describedabove. A user applies the wrap to the body part to be treated. The wrapis connected to a reservoir, pump, and other system components. The userthen turns on the system to flow fluid to the wrap for therapy.

One will appreciate from the description above various techniques forincreasing the bending strength and resistance to kinking in selectedregions of the fluid bladder, and in various respects, the therapeuticwrap. As described above, the kink-resistant features are confined to aspecific region of the fluid bladder. The positioning and area of aselective kink-resistant zone may depend on whether it is desirable toreinforce a specific fluid pathway or a general region of bending in thebladder. In various embodiments, the kink-resistant features are alignedwithin a fluidic channel or fluid pathway. In various embodiments, thekink-resistant features are aligned entirely within a fluidic channel orfluid pathway. In various embodiments, the kink-resistant featuresoverlap multiple fluidic channels or fluid pathways.

In various embodiments, the kink-resistant zone is distal from the inletand the outlet. As shown in FIGS. 5 and 6, for example, dot connectionsimmediately adjacent inlet and outlet manifold 54 have regular dotpatterns forming an essentially equilateral triangular pattern.

In various embodiments, the fluid bladder and/or wrap includes akink-resistant zone employing any combination of the above features. Invarious embodiments, the fluid bladder and/or wrap includes a pluralityof kink-resistant zone employing any combination of the above features.The kink-resistant zones may be spaced from each other or directlyadjacent one another. The features of the kink-resistant zones may becontiguous but separate elements. The features of the kink-resistantzones may be integrally formed thereby forming an integratedkink-resistant zone. In various embodiments, a sleeve and/orreinforcement layer embodying any of the features described herein isprovided.

A method of making and assembling the selectively reinforced therapeuticwrap in accordance with the invention will now be described. The wrapmay be manufactured using the techniques described above and known inthe art in accordance with the description herein.

For illustrative purposes, the method of manufacturing a wrap similar tothat shown in FIG. 9 will be described. One will appreciate that themethod may be modified to manufacture any of the wraps and heat exchangedevices described herein. For example, the method may be modified tomanufacture a heat-exchanging fluid bladder without a gas pressurebladder or sleeve.

FIGS. 10A, 10B, and 10C illustrate the general process for manufacturinga wrap similar to that shown in FIG. 9. The exemplary wrap includesreinforcement members 101 positioned adjacent middle layer 35 e and inthe gas pressure bladder 38 e.

FIG. 10A illustrates a dot layer processing operation. The first outerlayer 33 e is aligned with a middle layer 35 e. The sheets of materialare sealed together at dot connections 65 e and at interior fences 62 ethereby forming the basic outline of the fluid flowpath and fluidicchannels. At a later time, wall 60 e′ is welded to other walls 60 ealong the perimeter to form the fluid bladder. The dot connections andfences are generally prepared using conventional techniques. In oneembodiment, the connections are formed by RF welding.

The exemplary materials for the gas pressure bladder and fluid bladderare made of a nylon material coated with polyurethane to provide boththe RF welding qualities and the needed liquid or air impermeability.

In one embodiment, the bladders can comprise fabrics (e.g., nylonfabric) that are laminated with asymmetric amounts of polyurethane. Forexample, the inner surface of the outer wall of the coolant chamber mayhave an extra heavy coating. In one example, the outer coating comprisesabout 5 oz of polyurethane while the inner surfaces of the other wallshave standard coatings corresponding to about 3 oz of polyurethane.Accordingly, the surfaces of the inner wall of the coolant and airchambers and the inner surface of the outer wall of the air chamber havestandard 3 oz coatings. This construction only requires one non-standardfabric (the fabric having the 5 oz coating), while providing the extrapolyurethane necessary to produce an extremely robust weld capable oftaking or withstanding over 25,000 cycles at 30 psi. This constructioncan reduce manufacturing costs. It also facilitates using a lighterweight fabric, which can result in a more flexible heat exchanger thatcan better fit to the body.

In another embodiment, the inner wall of the coolant chamber has a 5 ozcoating of polyurethane in order to facilitate a yet stronger bond atthe expense of increased manufacturing costs due to the use of a secondnon-standard fabric. A finish on the nylon material can also provide apermanent antimicrobial finish to prevent mold growth.

FIG. 10B illustrates a fence layer of the manufacturing process. In FIG.10B, reinforcement members 101 are positioned over middle layer 35 e andaffixed with common techniques such as epoxy or welding. Thereinforcement members are aligned with the fluid flowpaths in thedesired locations.

Next, second outer layer 36 e is positioned over the sealed first layer33 e and middle layer 35 e. As shown in FIG. 10B, the exemplary threesheet layers have essentially the same shape to enable easy alignment.With the three layers and reinforcement members in position, all thelayers are sealed together along a common border and peripheral fence 62e. The sealing along the common border simultaneously forms the gaspressure bladder and fluid bladder. A space is left in the common borderto accommodate the inlet and outlet ports for the bladders.

The reinforcement layers may be assembled in various other ways. Invarious embodiments, the wrap includes a reinforcement layer having asubstrate supporting one or more reinforcement members in selectedlocations. The substrate enables easier assembly, in part, by making iteasier to align the reinforcing member or members with the fluid bladderand gas pressure bladder. The substrate and reinforcing member may bejoined together permanently, removable, or otherwise separate. Invarious embodiments, the substrate dimensions correspond to the fluidbladder periphery and inner dimensions of the sleeve such that thereinforcing layer can be aligned simply be inserting it into the sleevepouch next to the fluid bladder. In the exemplary wrap, the substrate isdimensioned to be applied over the fluid bladder whereby the reinforcingmember or members align with the desired fluidic channels.

Similarly, the reinforcement layer and/or reinforcement members may beformed concurrently with the bladder. Other manufacturing techniquesinclude, but are not limited to, spraying, molding, silk screening, andadhesives. One will appreciate that manufacturing techniques common inthe polymer and semiconductor fields may also be used such as etching,deposition, and lithography. Further details regarding the componentsand manufacturing techniques that may be used are disclosed in U.S. Pat.No. 7,198,093 to Elkins, the entire contents of which are incorporatedherein for all purposes.

Turning to FIG. 10C, after forming the bladders, excess material outsidethe common border is removed and manifold 54 is formed. Exemplary gaspressure bladder 38 e is formed with a single opening and fluid bladder37 e is formed with two openings to receive the tubes in the orientationshown in FIG. 10C. A tube, such as a polyurethane tube, is positioned ineach one of these openings and then welded to a respective bladder toform a fluid tight seal therewith. The tubes extending from the bladderstypically have an inner diameter of about ⅛ inch. The manifoldpassageways typically have a diameter of about ¼ inch. Manifold 54 canbe inserted into the tubes to form a seal therewith. For example, eachmanifold tubular member end portion that mates with or is inserted intoa respective tube extending from one or the other bladder can beprovided with tapered hose barbs to enhance the seal as is well known inthe art. Further details regarding the manifold construction aredisclosed in U.S. Patent Pub. No. 2009/0005841 to Schirrmacher et al.,the entire contents of which are incorporated herein for all purposes byreference. A fluid circulation control unit as diagrammaticallyrepresented in FIG. 1 and generally designated with reference numeral 39is coupled to manifold 54 with tubing to fluidly communicate the therapyfluids to bladders 37 and 38.

Although described in terms of a three-layer, dual-bladder design, onewill appreciate that the wrap and therapy system in accordance with theinvention may have other variations and modifications. In one example,although the wrap and therapy system described above generally has beendescribed with a dual bladder design, a single bladder heat exchangedevice can be used.

In another embodiment, the wrap in accordance with the invention isselectively reinforced by subjecting a selected portion of one or bothof materials 33 e and 35 e to stretching or pre-tensioning. One of skillin the art will appreciate that if one side of the bladder 37 e isstretched relative to the other, the bladder will tend towards a curvedshape. Likewise, selective pre-tensioning will form a selective contour.In various embodiments, the pre-tensioning is performed to form apredetermined curve in the resulting bladder that has a propensity towrap around a body part. The predetermined curve may have a radiusslightly larger than the body part so it provides a degree of tensionwhen wrapped while also reducing the risk of kinking.

Alternatively, the resulting bladder may be formed in a substantiallyflat shape with one wall or a portion of the bladder under stress(tension). The tension is then relieved when the bladder is forcedaround a body part. For example, one of the sheet materials may betensioned but held in a flat condition by the joining to the other sheetmaterial. In another example, the bladder may include a reinforcementmember to hold the resulting bladder in a flat condition.

The pre-tensioning may be performed in an otherwise conventional manneras will be understood from the description herein. For example, thematerial or materials may be placed in a mold and elongated orstretched. The material may also be heated to expand the dimensions andassembled while still expanded. The material may be anisotropic.

In an exemplary embodiment, a selected portion of first material 33 e ina kink-resistant zone is subjected to pre-tensioning. Alternatively,pre-tensioning may be applied to an entire layer of material. While thematerial remains in tension it is attached to middle layer 35 e. Theattachment may include forming a dot pattern, fence layer, and the likeas described above. The attachment may also be in an otherwiseconventional manner. Next the second outer layer is attached to themiddle layer and the manufacturing process is carried out as describedabove.

In the exemplary embodiment, the second outer layer and/or attachmentconnections keep the finished wrap in a generally planar state. When thewrap is placed around a curved body part, however, the tension in thepre-stretched kink-resistant zone is relieved. In this manner, the riskof kinking of the material is reduced without the need for aspecially-configured dot pattern or external reinforcement member. Invarious embodiments, heating is performed in addition to or in place ofpre-tensioning.

The above process may be modified. For example, the first and secondbladder may be formed simultaneously while the first material ispre-tensioned. Additionally, the middle layer and second layer mayinclude a selected pre-tensioned region instead of or in combinationwith the first layer.

FIGS. 10D-G illustrate an embodiment of a reinforcement member 101 whichcan be disposed within the gas pressure bladder to prevent or reducekinking in the gas bladder 38 e. The reinforcement member 101 can be afoam or sponge-like material having an open cell or porous structurethat is gas permeable and allows the passage of a gas through itselfwhile keeping the gas bladder 38 e open. In some embodiments, thereinforcement member can also be of a spacer fabric, mesh or non-porousmaterial. The reinforcement member 101 can be positioned along locationswhich are prone to kinking, such as at portions of the wrap 30 that arefolded or bent to conform to the patient's anatomy and/or to secure thewrap and/or are subject to flexure. For example, for a knee wrap, theportion of the wrap around the knee joint undergoes joint flexure, whichcan cause kinking of the wrap around the knee. By placing one or morereinforcement members 101 in the gas bladder around the portion of thewrap that is wrapped around the knee joint, kinking in the knee jointarea is prevented or reduced by allowing the gas to vent thru the porousstructural member, and/or around the edges of the structural member.Other kink prone areas include the transition area of the wrap betweenthe main body portion of the wrap and the various arms and/or wings ofthe wrap. The performance may be further enhanced by providing thereinforcement member in most of or the entire portion of the wrap.Further benefit may be added if the structural member has insulatingproperties to reduce ambient heat transfer. Therefore, in someembodiments, the reinforcing member can be an insulator or an insulatingmaterial. In some embodiments, an insulating reinforcing member can havean adhesive coating at least the side of the reinforcing member facingthe fluid bladder in order to improve contact between the insulatingreinforcing member and the middle layer of the fluid bladder, therebyimproving the insulation of the fluid bladder.

The reinforcement member 101 can be provided in a variety of shapes andsizes. For example, in some embodiments, the reinforcement member can bedonut or washer shaped, such that the reinforcement member can have acenter hole for attaching and securing the reinforcement member withinthe air bladder. For example, a spot weld can be placed within thecenter hole to secure the reinforcement member in place. In otherembodiments, the reinforcement member can have other shapes, such as anhourglass shape, an oval shape, an arc shape, a wavy or undulating orsinusoidal shape, a generally curvilinear shape, for example, asillustrated in FIGS. 10H and 10I. In some embodiments, the shape of thereinforcement member is defined by the surrounding and/or underlyingstructures in the gas bladder and fluid bladder. For example, theperimeter or border in the gas bladder formed by the peripheral fence 62e can define a portion of the shape and size of the reinforcement member101. In addition, interior fences 62 e, which can be disposed within thegas bladder and/or the fluid bladder, can also define the shape and sizeof the reinforcement member 101. Other perimeter and interior features,such as attachment points and welds in the gas bladder and/or fluidbladder can also be used to define the size and shape of thereinforcement member. In other embodiments, the reinforcement member canbe square, triangular, rectangular, hexagonal, or generally rectilinearshaped. In other embodiments, the reinforcement member can be shaped andsized to match the shape and size of the portion of the air bladder tobe reinforced. These alternatively shaped reinforcement members can alsohave one or more holes so that the reinforcement member can be spotwelded in place. In other embodiments, the reinforcement member can bespot welded or otherwise adhered or fastened directly to the layers thatform the gas bladder rather than spot welding the layers togetherthrough a hole in the reinforcement member.

In some embodiments, the reinforcement member 101 can be substantiallysmaller than the air bladder such that a plurality of reinforcementmembers can be placed in the kink prone area of the air bladder. Forexample, the reinforcement member 101 can be less than ⅓, ¼, ⅕, or 1/10the width or length of the kink prone region of the air bladder. Inother embodiments, the reinforcement member 101 can be approximately thesame size as the kink prone region. In some embodiments, the width ofthe reinforcement member can be less than or approximately equal to thewidth of the spacing between the spot welds. In some embodiments, thewidth of the reinforcement member can be a multiple of the spacingdistance between the spot welds.

Other techniques of fixing or staking the reinforcement member in placeinclude use of adhesives, which can be used alone or be used inconjunction with the other forms of fixation, such as spot welding. Whenthe adhesive is used in conjunction with another form of fixation, theadhesive may be tacky and provide releasable securement to allowrepositioning of the reinforcement member before being permanentlysecured in place, if desired. Other fixation techniques includestitching, hook and loop fasteners, buttons, riveting, snaps, and thelike. In some embodiments, the reinforcement member can be secured inplace by placing fixation features around the perimeter of thereinforcement member. The fixation features can be spot welds or otherguide members that hold the reinforcement member in place.

In some embodiments, the reinforcement member 101 can have a curved edgealong the kink prone area in order to reduce formation of a kink alongthe edge of the reinforcement member 101. In some embodiments, aplurality of reinforcement members 101 can be disposed in the kink proneregion. In some embodiments, the reinforcement members 101 can bedisposed in a predetermined staggered or offset pattern along the kinkprone region. In some embodiments, the reinforcement members can bedisposed in one or more rows.

FIGS. 10E-10G illustrate one embodiment for fabricating a wrap 30 withreinforcement members 101 within the gas bladder 38 e using a donut typereinforcement member 101 as described above. The first outer layer 33 eand middle layer 35 e can be assembled as described above to form thefluid bladder 37 e. The reinforcement members 101 can then be placed atpredetermined locations over remaining exposed surface of the middlelayer 35 e by centering the central hole of the reinforcement member 101over placement markers, which can be weld dots in the flowpath. In someembodiments, the weld dots used as placement markers may be of differentsize than other weld dots, or may be of different color, or may have amarking to identify it as a placement marker. In some embodiments, atemplate can be used to place the reinforcement members at predeterminedlocations. In some embodiments, the template can have cutouts forreceiving and placing the reinforcement members. In some embodiments,the reinforcement members 101 can be coated on one or both sides with atacky adhesive that holds the reinforcement member 101 in place duringthe assembly process. After the reinforcement members 101 are placed,the third layer 36 e can be placed over the middle layer 35 e andreinforcement members to form the gas bladder 38 e as described above.Welds can be made through the hole in the reinforcement member 101 tofurther secure the reinforcement member in place.

FIG. 11 illustrates an alternative design for a temperature-controlledtherapy device 30 f in accordance with the invention. Device 30 f issimilar in many respects to wrap 30 shown in FIG. 1 except that it doesnot include a compressive element and sleeve. The exemplary device is apad similar in various respects to the conventional pad described inU.S. Pat. No. 6,117,164 to Gildersleeve et al., the entire contents ofwhich is incorporated herein for all purposes by this reference. Whereaswrap 30 includes a compressive gas bladder 38, device 30 f is a singlechamber pad designed to carry a liquid heat exchanging medium only. Thedevice may be used alone or with a standard elastic wrap. For example,the device may include a fastener for attaching directly to a body partto be treated.

The exemplary fluid pad 30 f is a designed to fit over a knee orshoulder. The pad includes a fluidic flowpath for promoting a desiredflow even during joint flexure. In the exemplary embodiment of FIG. 11,pad 30 f includes a central portion intended to be positioned over ajoint.

Absent any reinforcement, pad 30 f is prone to kinking because of thetortuous fluid flowpath and complex shape including many twists, sharpradiuses, and fold lines. Accordingly, pad 30 f includes a dotconnection matrix with selective reinforcement as described above.Indeed, exemplary pad 30 f includes variable reinforcement wherebydifferent kink-prone regions have different levels of reinforcement. Asshown in FIG. 11, narrower portions of the flowpath have a dot patternwith lower distribution of dot connections than wider portions.

Dots 65 f in selected kink-resistant zones 73 f of the flowpath are inrandom alignment as described above to reduce the chance of kinking. Theexemplary pad 30 f has a winding fluid flowpath with a varying width. Aportion of the exemplary dot pattern varies based on the flowpath. Innarrow lateral sections the dots are spaced apart further. In a portionof the bladder where the flowpath makes a turn between the upwardlydirected side and the laterally extending upper section, the positioningof the exemplary dots forms more of a regular repeating triangularpattern.

For illustrative purposes, portion of the wrap are shown in dots ofvariable diameters. In an upper left part of FIG. 11, for example, thedot diameter increases moving from the center to the left side of thepad. One will appreciate from the description herein that varying thedot diameter can allow for adjustment of strength of only a localportion of the bladder.

In another example, device 30 f may include a separate reinforcementlayer with rigid reinforcement members in addition to or in lieu of theselectively reinforced dot pattern configuration. As will be clear fromthe above example, the reinforcement layer may be a separately-formed,independent member for use with a variety of temperature-controlledtherapy systems in accordance with the invention.

Exemplary device 30 f thus illustrates a number of other tools forselectively reinforcing a heat exchanger in accordance with theinvention. In combination with the dot spacing, dot positioning, fenceconfigurations, and other parameters discussed above, it will be clearthat the invention provides an assortment of techniques for improvingperformance over conventional temperature-controlled therapy devices. Invarious respects, the techniques described herein achieve the benefitsof high kink resistance while allowing the wrap to effectively conformto complex shapes. In addition, the flow and heat exchange performancecan be maintained or improved.

Various aspects of the invention are directed to a sleeve with selectivereinforcement for use with conventional fluid and/or gas bladders. Forexample, a sleeve may be provided similar to the sleeves described aboveexcept with a reinforcement layer. The reinforcement may be configuredwith selective reinforcement of only a portion of the sleeve. Theselective reinforcement may be in the form of a reinforcement structurepositioned in only a portion of the sleeve. The reinforcement layerand/or reinforcement member may be removable. The reinforcement memberhas a rigidity and strength significantly higher than the sleevematerial such that the sleeve resists kinking and/or bending in theselected region. In use, a plurality of sleeves with different selectedreinforcement regions may be provided. A user then selects a desiredsleeve and inserts one or more modular bladders. Thus, the componentscan be mixed and matched.

In some embodiments, the wrap can comprise only a gas bladder that canbe used to provide compressive treatment of a limb or other body part.The gas bladder only embodiment can be similar to the embodimentsdescribed above except for the absence of the fluid bladder. As such,the gas bladder can be fabricated from two layers of material, ratherthan three. In some embodiments, the gas bladder can include featuresthat have been described in connection with mainly the fluid bladder,such as attachment points and/or interior fences.

The above described embodiments may provide manufacturing and economicefficiencies. For example, a number of the components may bestandardized and supplied off-the-shelf or sold as kits. In variousembodiments, the wrap is assembled by providing a set of sleeves eachwith integrated reinforcement members and a pouch adapted to receive afluid bladder, selecting one of the sleeves, and inserting a bladderinto the sleeve. The plurality of sleeves may be dimensioned the samebut include different selective reinforcement patterns. Alternatively, aset of different selective reinforcement assemblies, each having asubstrate and one or more reinforcements as described herein, may beprovided. A user may then select and a pair a reinforcement assemblywith a selected sleeve and bladder. A user may also further customizethe wrap by inserting, removing, and/or modifying reinforcement members.

Variations and modifications of the devices and methods disclosed hereinwill be readily apparent to persons skilled in the art. As such, itshould be understood that the foregoing detailed description and theaccompanying illustrations, are made for purposes of clarity andunderstanding, and are not intended to limit the scope of the invention,which is defined by the claims appended hereto. Any feature described inany one embodiment described herein can be combined with any otherfeature of any of the other embodiment whether preferred or not.

It is understood that the examples and embodiments described herein arefor illustrative purposes only and that various modifications or changesin light thereof will be suggested to persons skilled in the art and areto be included within the spirit and purview of this application andscope of the appended claims. All publications, patents, and patentapplications cited herein are hereby incorporated by reference for allpurposes.

The invention is further illustrated by the Examples that follow. TheExamples are not intended to define or limit the scope of the invention.

EXAMPLES Example 1

A first wrap, referred to in some respects as the “first bladder” or the“reinforced bladder” and labeled as “Example A” in FIG. 12, was preparedsimilar to that shown in FIG. 1. The exemplary first wrap included arepeating equilateral triangle dot pattern forming fluidic channels. Thecenter-to-center dot spacing, which corresponds to the widths of thefluidic channels, was about 0.425″. The dot diameters were between about0.16″ and 0.2″.

The wrap was connected to a standard control unit and supplied with tapwater from an ice bath reservoir at approximately 19 psi. The bladderwas left in a flat condition in an ambient environment.

The bladder was then tested by displacing the fluid bladder with a2″-diameter force plate in a kink-prone region. The force plate wasapplied to the bladder with a screw. The force applied by the bladderagainst the disk was measured at different levels of displacement,generally 0.010″-0.015″ increments. The disk force was increased untilthe fluid bladder was completely occluded.

Next, a second fluid bladder, labeled as “Example B” in FIG. 12, wasprepared. Wrap Example B had a similar shape and overall dimensions asthe first wrap but included a conventional dot pattern. The second wraphad dots uniformly distributed in a regular triangular pattern acrossthe entire treatment surface. The dot pattern of the second bladdercomprised dots having a diameter of less than 0.15″ and center-to-centerspacing of about 0.33″.

The second fluid bladder was connected to the same control unit andsupplied with liquid at 19 psi. The same test was then conducted on thesecond fluid bladder. The fluid bladder was displaced with the2″-diameter disk in the same spot as the first bladder. The forceapplied by the bladder against the disk was measured at the samedisplacement increments until the fluid bladder was completely occluded.

At about 0.14″ of displacement, the first bladder exerted 1.5 pounds offorce versus 0.5 pounds for the second bladder. At about 0.13″, theforce of the first bladder was 5.6 pounds and the force of the secondbladder was only 1.4 pounds. At about 0.11″, the force of the firstbladder was 11.3 pounds and the force of the second bladder was only 3.8pounds. At about 0.1″, the force of the first bladder was 17 pounds andthe force of the second bladder was only 10.8 pounds. At about 0.09″,the force of the first bladder was 22.2 pounds and the force of thesecond bladder was only 19 pounds. At about 0.08″, the force of thefirst bladder was 27.8 pounds and the force of the second bladder wasonly 25.6 pounds.

The complete results are shown in the graph of FIG. 12.

The test results illustrate that the force applied by the first fluidbladder was measurably higher than the second bladder at each givendisplacement. This force may be generally referred to as the“restorative force” or “resistive force”. In some respects, all thingsbeing equal, the greater the “restorative force” the less likely it isfor the fluidic channel to become kinked. Conversely, the first bladderwas deflected to a lesser degree than the second bladder at each givenforce level. Thus, the dot spacing was critical to improving kinkresistance.

The results in FIG. 12 also illustrate that the force to achievecomplete displacement (occlusion) is higher in the first bladder withreinforcement.

The test results demonstrate that reinforcement in accordance with theinvention increases the kinking force required to displace, andultimately occlude, the fluidic channels. The increase in performancemay be represented as the area between the two lines. This arearepresents an improved flow of the first bladder at the same force(pressure) levels as the conventional second bladder.

Moreover, the results in illustrate that the onset of complete occlusionfailure is more gradual with the selectively reinforced bladder. Theimprovement in kink resistance was also shown to be attainable without acommensurate large increase in a volume of the bladder.

It is noted that the pressure range(s) for the test results of FIG. 12are illustrative of the expected forces on the bladder during operation.The fluid was pumped to the bladders at 19 psi, which is typical forsuch bladder. The higher force values (e.g. 35 psi) are believed to betypical of the force levels experienced by selected kink-prone regionsof the wrap when the wrap is attached to a body part and compressed.These kink-prone regions can experience pressures several orders ofmagnitude higher than the pump pressure.

The two bladders were also informally tested for operationaleffectiveness. The first bladder with selective reinforcement was foundto have generally improved performance. In particular, the first bladderwas found to provide one or more of the following benefits: improvedheat exchange through better flow rates when in compression, reducedrisk of failure from blocked fluid pathways and more even temperaturesdue to open flowpaths.

Example 2

The same two fluid bladders were tested again under the same conditionsexcept the fluid pressure was decreased to 10 psi. The results are shownin FIG. 13 where “Example A” refers to the same first bladder withreinforcement and “Example B” refers to the same second bladder withoutreinforcement, as described above.

Again, the results of this Example demonstrate that the force from thefirst bladder is generally higher at each given displacement level. Infact, as the displacement increases, the gap between the restoring forcein the first bladder and the restoring force in the second bladderincreases. Thus, the fluidic channels defined by the kink-resistant dotpattern in the first bladder are shown to provide increased resistanceto kinking.

Example 3

The same two wraps above were provided. A third wrap having aconventional dot pattern was provided. The three wraps were filled withtap water. The water volume in the wrap per surface area of the wrap wasmeasured versus the pressure to fill the wrap. The results are shown inFIG. 14 where “Example A”, “Example B”, and “Example C” are the resultsfor the three exemplary wraps.

The bladder of Example A corresponds to the first bladder withreinforcement described in Example 1 above. The bladder of Example Bcorresponds to the second, conventional bladder of Example 1 above.Example C was similar to Example B in terms of relative dot spacing buthad larger fluid bladder. FIG. 14 shows how volume/surface areacorresponds to pressure for the three wraps.

The results shown in FIG. 14 illustrate that a large fluid volume(Example C) is not functional at even moderate pressures, namely, aboveabout 15 psi. Example C generally exhibited inferior performance at lowpressure as well. For example, the bladder took longer to fill andcirculate than desirable for typical operating settings. In large partbecause of the pressure limitations, the pump pressure and flow ratecould not be increased to compensate for the larger volume either.

Between Example A and Example B, Example A—the reinforced bladder—wasfound to perform as well as Example B but experienced kinking less oftenacross a wide pressure range. The wrap of Example B experiencedoccasional problems with kinking, whether partial or complete blockingof the fluid pathway. By contrast, the wrap of Example A experiencedsignificantly less occurrences of kinking without deteriorating otherperformance factors.

What is claimed is:
 1. A therapy wrap for providing heating or coolingto an anatomical body part, the wrap comprising: a flexible fluidbladder for containing a heat exchange medium, the fluid bladderincluding an inlet, an outlet, and a fluid flowpath connecting the inletand the outlet; a gas pressure bladder overlaying the fluid bladder forapplying a compressive force to a portion of the fluid bladder incontact with the body part; and a reinforcement member disposed withinthe gas pressure bladder at one or more kink prone regions of the gaspressure bladder, wherein the reinforcement member reduces kinking atthe one or more kink prone regions of the gas pressure bladder.
 2. Thetherapy wrap of claim 1, wherein the reinforcement member is a made froma porous material.
 3. The therapy wrap of claim 2, wherein the porousmaterial has an open cell foam structure that is gas permeable.
 4. Thetherapy wrap of claim 1, wherein the reinforcement member has a hole anda weld that passes through the hole that secures the reinforcementmember within the gas pressure bladder.
 5. The therapy wrap of claim 4,wherein the reinforcement member is donut shaped.
 6. The therapy wrap ofclaim 1, wherein the reinforcement member is secured to the gas pressurebladder with an adhesive.
 7. The therapy wrap of claim 1, furthercomprising a plurality of attachment points connecting walls of thebladder and defining a plurality of fluidic channels in the flow path.8. The therapy wrap of claim 7, wherein the reinforcement member issecured within the gas pressure bladder with a weld that is aligned withone of the attachment points.
 9. The therapy wrap of claim 7, whereinthe size and shape of the reinforcement member is defined at least inpart by one or more of the plurality of attachment points within thebladder.
 10. The therapy wrap of claim 1, wherein the reinforcementmember is curvilinear.
 11. The therapy wrap of claim 10, wherein thereinforcement member is circular or oval.
 12. The therapy wrap of claim1, wherein the reinforcement member is rectilinear.
 13. The therapy wrapof claim 12, wherein the reinforcement member is square or rectangular.14. The therapy wrap of claim 1, wherein the size and shape of thereinforcement member is defined at least in part by a perimeter of thegas pressure bladder.
 15. The therapy wrap of claim 1, wherein the sizeand shape of the reinforcement member is defined at least in part by oneor more interior fences disposed within the fluid bladder or gaspressure bladder.
 16. The therapy wrap of claim 1, wherein thereinforcement member is made from an insulating material.
 17. Thetherapy wrap of claim 16, wherein reinforcement member is adhered to awall of the gas pressure bladder that is adjacent or shared with thefluid bladder.
 18. A therapy wrap for providing treatment to ananatomical body part, the wrap comprising: a gas pressure bladder forapplying a compressive force to the body part; and a reinforcementmember disposed within the gas pressure bladder at one or more kinkprone regions of the gas pressure bladder, wherein the reinforcementmember reduces kinking at the one or more kink prone regions of the gaspressure bladder.
 19. The therapy wrap of claim 18, wherein thereinforcement member is a made from a porous material.
 20. The therapywrap of claim 19, wherein the porous material has an open cell foamstructure that is gas permeable.
 21. The therapy wrap of claim 18,wherein the reinforcement member has a hole and a weld that passesthrough the hole that secures the reinforcement member within the gaspressure bladder.
 22. The therapy wrap of claim 21, wherein thereinforcement member is donut shaped.
 23. The therapy wrap of claim 18,wherein the reinforcement member is secured to the gas pressure bladderwith an adhesive.
 24. The therapy wrap of claim 18, wherein thereinforcement member is secured within the gas pressure bladder with oneor more welds.
 25. The therapy wrap of claim 18, wherein thereinforcement member is curvilinear.
 26. The therapy wrap of claim 25,wherein the reinforcement member is circular or oval.
 27. The therapywrap of claim 18, wherein the reinforcement member is rectilinear. 28.The therapy wrap of claim 27, wherein the reinforcement member is squareor rectangular.
 29. The therapy wrap of claim 18, wherein the size andshape of the reinforcement member is defined at least in part by aperimeter of the gas pressure bladder.
 30. The therapy wrap of claim 18,wherein the size and shape of the reinforcement member is defined atleast in part by one or more interior attachment features disposedwithin the gas pressure bladder.